Trial Outcomes & Findings for Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS) (NCT NCT01131312)
NCT ID: NCT01131312
Last Updated: 2018-11-20
Results Overview
A cervical exam, pap test, human papilloma virus (HPV) deoxyribonucleic acid (DNA) test, and/or colposcopy was performed to detect whether or not a participant had CINIII. CINIII is defined as moderate or severe dysplasia or abnormal cells located on the cervix that can lead to cancer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5060 participants
Primary outcome timeframe
up to 2 years
Results posted on
2018-11-20
Participant Flow
Participant milestones
| Measure |
Cytology
Referred to colposcopy if cytology is high grade
Thinprep: Pap test
|
Human Papillomavirus (HPV)
Referred to colposcopy if cytology is high grade or HPV +
Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test
|
Colposcopy
All refer to colposcopy
Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1839
|
1385
|
1836
|
|
Overall Study
COMPLETED
|
1414
|
1156
|
1485
|
|
Overall Study
NOT COMPLETED
|
425
|
229
|
351
|
Reasons for withdrawal
| Measure |
Cytology
Referred to colposcopy if cytology is high grade
Thinprep: Pap test
|
Human Papillomavirus (HPV)
Referred to colposcopy if cytology is high grade or HPV +
Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test
|
Colposcopy
All refer to colposcopy
Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
425
|
229
|
351
|
Baseline Characteristics
Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)
Baseline characteristics by cohort
| Measure |
Cytology
n=1839 Participants
Referred to colposcopy if cytology is high grade
Thinprep: Pap test
|
Human Papillomavirus (HPV)
n=1385 Participants
Referred to colposcopy if cytology is high grade or HPV +
Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test
|
Colposcopy
n=1836 Participants
All refer to colposcopy
Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva.
|
Total
n=5060 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
103 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1729 Participants
n=5 Participants
|
1313 Participants
n=7 Participants
|
1729 Participants
n=5 Participants
|
4771 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Continuous
|
27.22 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
28.28 years
STANDARD_DEVIATION 9.62 • n=7 Participants
|
27.24 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
27.52 years
STANDARD_DEVIATION 9.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1839 Participants
n=5 Participants
|
1385 Participants
n=7 Participants
|
1836 Participants
n=5 Participants
|
5060 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
81 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1754 Participants
n=5 Participants
|
1317 Participants
n=7 Participants
|
1751 Participants
n=5 Participants
|
4822 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
41 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
48 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
559 Participants
n=5 Participants
|
427 Participants
n=7 Participants
|
569 Participants
n=5 Participants
|
1555 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1180 Participants
n=5 Participants
|
865 Participants
n=7 Participants
|
1146 Participants
n=5 Participants
|
3191 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1839 Participants
n=5 Participants
|
1385 Participants
n=7 Participants
|
1836 Participants
n=5 Participants
|
5060 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsA cervical exam, pap test, human papilloma virus (HPV) deoxyribonucleic acid (DNA) test, and/or colposcopy was performed to detect whether or not a participant had CINIII. CINIII is defined as moderate or severe dysplasia or abnormal cells located on the cervix that can lead to cancer.
Outcome measures
| Measure |
Cytology
n=1839 Participants
Referred to colposcopy if cytology is high grade
Thinprep: Pap test
|
Human Papillomavirus (HPV)
n=1385 Participants
Referred to colposcopy if cytology is high grade or HPV +
Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test
|
Colposcopy
n=1836 Participants
All refer to colposcopy
Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva.
|
|---|---|---|---|
|
Percentage of Participants With Cervical Intraepithelial Neoplasia III (CIN III)
|
10.93 percentage of participants
|
10.25 percentage of participants
|
10.84 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 yearsCumulative detection of CIN2 and above was assessed by pathologists who reviewed specimens from cervical pelvic exams (i.e. thin prep pap test, Human papillomavirus (HPV) Deoxyribonucleic acid (DNA) test, and/or colposcopy). Pathologists graded the specimens from CIN2 (moderate grade lesion) to CIN3 (high grade lesion).
Outcome measures
| Measure |
Cytology
n=1839 Participants
Referred to colposcopy if cytology is high grade
Thinprep: Pap test
|
Human Papillomavirus (HPV)
n=1385 Participants
Referred to colposcopy if cytology is high grade or HPV +
Hybrid capture 2: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test
|
Colposcopy
n=1836 Participants
All refer to colposcopy
Colposcopy: Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva.
|
|---|---|---|---|
|
Percentage of Participants With Cumulative Detection of Clinical Center Histologically Confirmed Cervical Intraepithelial Neoplasia 2 (CIN2) and Above (High Grade Lesion) Over the 2 Years of the Trial.
|
16.69 percentage of particpants
|
18.12 percentage of particpants
|
20.75 percentage of particpants
|
Adverse Events
Cytology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Human Papillomavirus (HPV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colposcopy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place