Trial Outcomes & Findings for S1204, Viral Screening in Newly Diagnosed Cancer Patients (NCT NCT01946516)

NCT ID: NCT01946516

Last Updated: 2023-07-03

Results Overview

An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics.

Recruitment status

COMPLETED

Target enrollment

3051 participants

Primary outcome timeframe

Up to 21 days after registration

Results posted on

2023-07-03

Participant Flow

3092 participants were screened for the trial; 41 were deemed ineligible and 3051 eligible participants were registered to the trial.

Participant milestones

Participant milestones
Measure
HBV, HCV, or HIV Prevalence
Participants received testing for at least one of the following, HBV, HCV, or HIV.
Overall Study
STARTED
3051
Overall Study
Evaluated for HBV Status
3050
Overall Study
Evaluated for HCV Status
2990
Overall Study
Evaluated for HIV Status
3045
Overall Study
COMPLETED
3051
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

S1204, Viral Screening in Newly Diagnosed Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Participants With Newly Diagnosed Cancer
n=3051 Participants
Participants with newly diagnosed cancer that underwent viral testing for at least one of the following: HBV, HCV, and HIV.
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
1967 Participants
n=93 Participants
Age, Categorical
>=65 years
1084 Participants
n=93 Participants
Age, Continuous
60.6 years
n=93 Participants
Sex: Female, Male
Female
1842 Participants
n=93 Participants
Sex: Female, Male
Male
1209 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
558 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2478 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
15 Participants
n=93 Participants
Race/Ethnicity, Customized
Race · White
2281 Participants
n=93 Participants
Race/Ethnicity, Customized
Race · Black
553 Participants
n=93 Participants
Race/Ethnicity, Customized
Race · Asian
102 Participants
n=93 Participants
Race/Ethnicity, Customized
Race · Other
115 Participants
n=93 Participants
Cancer Type
Blood or marrow
369 Participants
n=93 Participants
Cancer Type
Breast
1058 Participants
n=93 Participants
Cancer Type
Gastrointestinal tract, colorectal
362 Participants
n=93 Participants
Cancer Type
Gastrointestinal, liver
62 Participants
n=93 Participants
Cancer Type
Gastrointestinal, other
235 Participants
n=93 Participants
Cancer Type
Head and neck
112 Participants
n=93 Participants
Cancer Type
Lung
356 Participants
n=93 Participants
Cancer Type
Prostate
100 Participants
n=93 Participants
Cancer Type
Other
392 Participants
n=93 Participants
Cancer Type
Missing
5 Participants
n=93 Participants
Region
West and Midwest United States
1096 Participants
n=93 Participants
Region
South and Northeast United States
1955 Participants
n=93 Participants

PRIMARY outcome

Timeframe: Up to 21 days after registration

Population: The analysis population includes the 3051 participants eligible to receive at least one viral test (for HBV, HCV, or HIV). 3050 participants were evaluable for HBV analysis (1 participants had no HBV test results available), 2990 participants were evaluable for HCV analysis (5 participants had no HCV test results available and 56 participants incomplete test results), and 3045 participants were evaluable for HIV analysis (6 participants had no HIV test results available).

An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics.

Outcome measures

Outcome measures
Measure
Evaluated for Chronic HBV
n=3050 Participants
Participants who were evaluated for chronic HBV.
Evaluated for Previous HBV
n=3050 Participants
Participants who were evaluated for previous HBV analysis.
Evaluated for HCV
n=2990 Participants
Participants who were evaluated for HCV..
Evaluated for HIV
n=3045 Participants
Participants who were evaluated for HIV analysis.
Participants With Any Type Of Viral Infection
Participants diagnosed with any type of viral infection.
Number of Participants With Positive Viral Infection
Positive Viral Test in All Participants
19 Participants
197 Participants
71 Participants
34 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Newly Diagnosed Participants
8 Participants
172 Participants
22 Participants
2 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Blood/Marrow Cancer
2 Participants
16 Participants
9 Participants
7 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Prostate Cancer
0 Participants
12 Participants
3 Participants
1 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Previously Diagnosed Participants
11 Participants
25 Participants
49 Participants
32 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Breast Cancer
4 Participants
66 Participants
9 Participants
2 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Colorectal Cancer
2 Participants
18 Participants
7 Participants
5 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Liver Cancer
4 Participants
5 Participants
9 Participants
0 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with GI, Other Tract Cancer
3 Participants
22 Participants
3 Participants
5 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Head and Neck Cancer
1 Participants
9 Participants
5 Participants
1 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Lung Cancer
2 Participants
31 Participants
17 Participants
4 Participants
Number of Participants With Positive Viral Infection
Positive Viral Test in Participants with Other Cancer
1 Participants
18 Participants
9 Participants
9 Participants

SECONDARY outcome

Timeframe: Up to 21 days after registration

Population: The analysis population includes the 2940 of the 3050 participants who were evaluable for HBV analysis and completed the risk factor survey.

The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated.

Outcome measures

Outcome measures
Measure
Evaluated for Chronic HBV
n=190 Participants
Participants who were evaluated for chronic HBV.
Evaluated for Previous HBV
n=2750 Participants
Participants who were evaluated for previous HBV analysis.
Evaluated for HCV
Participants who were evaluated for HCV..
Evaluated for HIV
Participants who were evaluated for HIV analysis.
Participants With Any Type Of Viral Infection
Participants diagnosed with any type of viral infection.
Presence of Important Risk Factors in Participants Tested for Previous HBV
Needle-stick exposure · Risk Factor Present
12 Participants
136 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Needle-stick exposure · Risk Factor Absent
178 Participants
2614 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Household contact with hepatitis-positive person · Risk Factor Present
15 Participants
171 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Unprotected sex with MSM, multiple, or anonymous partners · Risk Factor Present
14 Participants
103 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Unprotected sex with MSM, multiple, or anonymous partners · Risk Factor Absent
176 Participants
2647 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Household contact with hepatitis-positive person · Risk Factor Absent
175 Participants
2579 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
High-risk occupation · Risk Factor Present
11 Participants
190 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
High-risk occupation · Risk Factor Absent
179 Participants
2560 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Completed HBV vaccine (3 or more doses) · Risk Factor Present
8 Participants
236 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Completed HBV vaccine (3 or more doses) · Risk Factor Absent
182 Participants
2514 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Sexual contact with HIV-positive person · Risk Factor Present
14 Participants
25 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Sexual contact with HIV-positive person · Risk Factor Absent
176 Participants
2725 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Self-reported infection with HCV or HIV · Risk Factor Present
41 Participants
135 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Self-reported infection with HCV or HIV · Risk Factor Absent
149 Participants
2615 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Born in high HBV prevalence region · Risk Factor Present
63 Participants
243 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Born in high HBV prevalence region · Risk Factor Absent
127 Participants
2507 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Injected drug use · Risk Factor Present
21 Participants
86 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Injected drug use · Risk Factor Absent
169 Participants
2664 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Unprotected sex with high-risk person · Risk Factor Present
21 Participants
109 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Unprotected sex with high-risk person · Risk Factor Absent
169 Participants
2641 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Sexual contact with hepatitis-positive person · Risk Factor Present
10 Participants
56 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Sexual contact with hepatitis-positive person · Risk Factor Absent
180 Participants
2694 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Diagnosis or treatment for STD · Risk Factor Present
32 Participants
276 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Diagnosis or treatment for STD · Risk Factor Absent
158 Participants
2474 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Blood transfusion between 1978-1985 · Risk Factor Present
13 Participants
110 Participants
Presence of Important Risk Factors in Participants Tested for Previous HBV
Blood transfusion between 1978-1985 · Risk Factor Absent
177 Participants
2640 Participants

SECONDARY outcome

Timeframe: Up to 21 days after registration

Population: The analysis population includes the 2940 of the 3050 participants who were evaluable for HBV analysis and completed the risk factor survey.

The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated.

Outcome measures

Outcome measures
Measure
Evaluated for Chronic HBV
n=18 Participants
Participants who were evaluated for chronic HBV.
Evaluated for Previous HBV
n=2922 Participants
Participants who were evaluated for previous HBV analysis.
Evaluated for HCV
Participants who were evaluated for HCV..
Evaluated for HIV
Participants who were evaluated for HIV analysis.
Participants With Any Type Of Viral Infection
Participants diagnosed with any type of viral infection.
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Needle-stick exposure · Risk Factor Absent
15 Participants
2777 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Diagnosis or treatment for STD · Risk Factor Absent
14 Participants
2618 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Self-reported infection with HCV or HIV · Risk Factor Present
2 Participants
174 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Born in high HBV prevalence region · Risk Factor Present
8 Participants
298 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Born in high HBV prevalence region · Risk Factor Absent
10 Participants
2624 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Needle-stick exposure · Risk Factor Present
3 Participants
145 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Unprotected sex with MSM, multiple, or anonymous partners · Risk Factor Present
2 Participants
115 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Unprotected sex with MSM, multiple, or anonymous partners · Risk Factor Absent
16 Participants
2807 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Unprotected sex with high-risk person · Risk Factor Present
2 Participants
128 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Unprotected sex with high-risk person · Risk Factor Absent
16 Participants
2794 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Sexual contact with hepatitis-positive person · Risk Factor Present
1 Participants
65 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Sexual contact with hepatitis-positive person · Risk Factor Absent
17 Participants
2857 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Diagnosis or treatment for STD · Risk Factor Present
4 Participants
304 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Self-reported infection with HCV or HIV · Risk Factor Absent
16 Participants
2748 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Household contact with hepatitis-positive person · Risk Factor Present
1 Participants
185 Participants
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Household contact with hepatitis-positive person · Risk Factor Absent
17 Participants
2737 Participants

SECONDARY outcome

Timeframe: Up to 21 days after registration

Population: The analysis population includes the 2882 of the 2990 participants who were evaluable for HCV analysis completed the risk factor survey.

The presence or absence of specific risk factors among participants evaluated for HCV is evaluated.

Outcome measures

Outcome measures
Measure
Evaluated for Chronic HBV
n=69 Participants
Participants who were evaluated for chronic HBV.
Evaluated for Previous HBV
n=2813 Participants
Participants who were evaluated for previous HBV analysis.
Evaluated for HCV
Participants who were evaluated for HCV..
Evaluated for HIV
Participants who were evaluated for HIV analysis.
Participants With Any Type Of Viral Infection
Participants diagnosed with any type of viral infection.
Presence of Important Risk Factors in Participants Tested for HCV
Injected drug use · Risk Factor Absent
48 Participants
2746 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Tested because born between 1945-1965 · Risk Factor Absent
58 Participants
2687 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Self-reported infection with HIV · Risk Factor Present
4 Participants
48 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Injected drug use · Risk Factor Present
21 Participants
67 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Tested because of blood exposure, injected drug use, or transfusion before 1992 · Risk Factor Present
9 Participants
45 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Tested because of blood exposure, injected drug use, or transfusion before 1992 · Risk Factor Absent
60 Participants
2768 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Tested because of symptoms · Risk Factor Present
7 Participants
46 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Tested because of symptoms · Risk Factor Absent
62 Participants
2767 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Blood transfusion between 1978-1985 · Risk Factor Present
11 Participants
104 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Blood transfusion between 1978-1985 · Risk Factor Absent
58 Participants
2709 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Tested because born between 1945-1965 · Risk Factor Present
11 Participants
126 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Self-reported infection with HIV · Risk Factor Absent
65 Participants
2765 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Snorted cocaine · Risk Factor Present
15 Participants
254 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Snorted cocaine · Risk Factor Absent
54 Participants
2559 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Needle-stick exposure · Risk Factor Present
7 Participants
134 Participants
Presence of Important Risk Factors in Participants Tested for HCV
Needle-stick exposure · Risk Factor Absent
62 Participants
2679 Participants
Presence of Important Risk Factors in Participants Tested for HCV
High-risk occupation · Risk Factor Present
3 Participants
195 Participants
Presence of Important Risk Factors in Participants Tested for HCV
High-risk occupation · Risk Factor Absent
66 Participants
2618 Participants

SECONDARY outcome

Timeframe: Up to 21 days after registration

Population: The analysis population includes the 2934 of the 3045 participants were evaluable for HIV analysis and completed the risk factor survey.

The presence or absence of specific risk factors among participants evaluated for HIV is evaluated.

Outcome measures

Outcome measures
Measure
Evaluated for Chronic HBV
n=34 Participants
Participants who were evaluated for chronic HBV.
Evaluated for Previous HBV
n=2900 Participants
Participants who were evaluated for previous HBV analysis.
Evaluated for HCV
Participants who were evaluated for HCV..
Evaluated for HIV
Participants who were evaluated for HIV analysis.
Participants With Any Type Of Viral Infection
Participants diagnosed with any type of viral infection.
Presence of Important Risk Factors in Participants Tested for HIV
Sexual contact with HIV-positive person · Risk Factor Present
16 Participants
23 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Sexual contact with HIV-positive person · Risk Factor Absent
18 Participants
2877 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Unprotected sex with MSM, multiple, or anonymous partners · Risk Factor Present
16 Participants
101 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Unprotected sex with MSM, multiple, or anonymous partners · Risk Factor Absent
18 Participants
2799 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Diagnosis or treatment for STD · Risk Factor Present
20 Participants
288 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Diagnosis or treatment for STD · Risk Factor Absent
14 Participants
2612 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Unprotected sex with high-risk person · Risk Factor Present
12 Participants
118 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Unprotected sex with high-risk person · Risk Factor Absent
22 Participants
2782 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Self-reported infection with HBV · Risk Factor Present
4 Participants
51 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Self-reported infection with HBV · Risk Factor Absent
30 Participants
2849 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Diagnosis or treatment for tuberculosis · Risk Factor Present
5 Participants
92 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Diagnosis or treatment for tuberculosis · Risk Factor Absent
29 Participants
2808 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Injected drug use · Risk Factor Present
3 Participants
104 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Injected drug use · Risk Factor Absent
31 Participants
2796 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Needle-stick exposure · Risk Factor Present
1 Participants
147 Participants
Presence of Important Risk Factors in Participants Tested for HIV
Needle-stick exposure · Risk Factor Absent
33 Participants
2753 Participants
Presence of Important Risk Factors in Participants Tested for HIV
High-risk occupation · Risk Factor Present
1 Participants
199 Participants
Presence of Important Risk Factors in Participants Tested for HIV
High-risk occupation · Risk Factor Absent
33 Participants
2701 Participants

SECONDARY outcome

Timeframe: 60 days after registration

Population: The analysis population includes the 224 participants who were viral positive for at least one viral test (for HBV, HCV, or HIV) and had treatment outcome data available. Of the 292 patients were who were viral positive for at least one viral test, 11 patients did not have data submitted and 57 patients did not have data available.

Among participants with HIV, HBV, or HCV, the timing and type of treatments received, both for the viral infections and the cancers that were evaluated.

Outcome measures

Outcome measures
Measure
Evaluated for Chronic HBV
n=152 Participants
Participants who were evaluated for chronic HBV.
Evaluated for Previous HBV
n=15 Participants
Participants who were evaluated for previous HBV analysis.
Evaluated for HCV
n=49 Participants
Participants who were evaluated for HCV..
Evaluated for HIV
n=30 Participants
Participants who were evaluated for HIV analysis.
Participants With Any Type Of Viral Infection
n=224 Participants
Participants diagnosed with any type of viral infection.
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
Received Antiviral or Antiretroviral Drugs
11.8 percentage of participants
73.3 percentage of participants
8.2 percentage of participants
66.7 percentage of participants
19.6 percentage of participants
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
Change in Cancer Treatment
59.2 percentage of participants
53.3 percentage of participants
55.1 percentage of participants
50 percentage of participants
58.5 percentage of participants
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
Change in Cancer Treatment due to Viral Positive Status
7.9 percentage of participants
13.3 percentage of participants
6.1 percentage of participants
16.7 percentage of participants
8 percentage of participants
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
Change in Cancer Treatment due to Viral Positive Status and Added Antiviral or Antiretroviral Drugs
5.3 percentage of participants
13.3 percentage of participants
2 percentage of participants
13.3 percentage of participants
6.3 percentage of participants

SECONDARY outcome

Timeframe: 5 years after registration

Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years after registration

Estimate the cost-effectiveness of screening for HIV, HBV, and HCV.

Outcome measures

Outcome data not reported

Adverse Events

HBV, HCV, or HIV Prevalence

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cancer Care Delivery Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60