Trial Outcomes & Findings for Human Papillomavirus Infection and Virus Genotyping in Uterine Cervix Cancer in Venezuela (NCT NCT00937547)
NCT ID: NCT00937547
Last Updated: 2012-12-04
Results Overview
HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer
Recruitment status
COMPLETED
Target enrollment
329 participants
Primary outcome timeframe
6 months
Results posted on
2012-12-04
Participant Flow
Samples were collected from files between 2001-2011
14 samples were excluded because of misdiagnosis.
Participant milestones
| Measure |
Invasive Cervical Cancer
patients with histologic diagnosis invasive cervical cancer.
|
Cervical Intraepithelial Neoplasia 2
patients with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
Cervical Intraepithelial Neoplasia 3
patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
|---|---|---|---|
|
Overall Study
STARTED
|
96
|
84
|
149
|
|
Overall Study
Histological Samples
|
95
|
78
|
142
|
|
Overall Study
COMPLETED
|
95
|
78
|
142
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
7
|
Reasons for withdrawal
| Measure |
Invasive Cervical Cancer
patients with histologic diagnosis invasive cervical cancer.
|
Cervical Intraepithelial Neoplasia 2
patients with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
Cervical Intraepithelial Neoplasia 3
patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
|---|---|---|---|
|
Overall Study
misdiagnosis
|
1
|
6
|
7
|
Baseline Characteristics
Human Papillomavirus Infection and Virus Genotyping in Uterine Cervix Cancer in Venezuela
Baseline characteristics by cohort
| Measure |
Invasive Cervical Cancer
n=96 Participants
Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
|
Intraepithelial Cervical Neoplasia 3
n=149 Participants
Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Intraepithelial Cervical Neoplasia 2
n=84 Participants
Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
317 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age Continuous
|
44.5 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
39.27 years
STANDARD_DEVIATION 11.12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
329 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
|
|
Region of Enrollment
Venezuela
|
96 participants
n=5 Participants
|
149 participants
n=7 Participants
|
84 participants
n=5 Participants
|
329 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsHPV distribution was identified in CIN2, CIN3 and invasive cervical cancer
Outcome measures
| Measure |
Invasive Cervical Cancer
n=96 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=149 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=84 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Identification
|
95 biopsies
|
142 biopsies
|
78 biopsies
|
PRIMARY outcome
Timeframe: 6 monthsNumber of biopsies positive to HPV 16.
Outcome measures
| Measure |
Invasive Cervical Cancer
n=95 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=142 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=78 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Type 16
|
65 biopsies
|
90 biopsies
|
35 biopsies
|
PRIMARY outcome
Timeframe: 6 monthsNumber of biopsies positive to HPV 18.
Outcome measures
| Measure |
Invasive Cervical Cancer
n=95 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=142 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=78 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Type 18
|
11 biopsies
|
14 biopsies
|
5 biopsies
|
PRIMARY outcome
Timeframe: 6 monthsNumber of biopsies positive to HPV 31.
Outcome measures
| Measure |
Invasive Cervical Cancer
n=95 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=142 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=78 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Type 31
|
6 biopsies
|
10 biopsies
|
8 biopsies
|
PRIMARY outcome
Timeframe: 6 monthsNumber of biopsies positive to HPV 33.
Outcome measures
| Measure |
Invasive Cervical Cancer
n=95 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=142 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=78 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Type 33
|
6 biopsies
|
10 biopsies
|
5 biopsies
|
PRIMARY outcome
Timeframe: 6 monthsNumber of biopsies positive to HPV 45.
Outcome measures
| Measure |
Invasive Cervical Cancer
n=95 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=142 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=78 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Type 45
|
6 biopsies
|
6 biopsies
|
5 biopsies
|
PRIMARY outcome
Timeframe: 6 monthsNumber of biopsies positive to HPV 58.
Outcome measures
| Measure |
Invasive Cervical Cancer
n=95 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=142 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=78 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Type 58
|
3 biopsies
|
7 biopsies
|
5 biopsies
|
PRIMARY outcome
Timeframe: 6 monthsNumber of biopsies positive to HPV 51.
Outcome measures
| Measure |
Invasive Cervical Cancer
n=95 Participants
Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
|
Cervical Intraepithelial Neoplasia 3
n=142 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
|
Cervical Intraepithelial Neoplasia 2
n=78 Participants
Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
|
|---|---|---|---|
|
HPV Type 51
|
1 biopsies
|
5 biopsies
|
7 biopsies
|
Adverse Events
Invasive Cervical Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intraepithelial Cervical Neoplasia 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intraepithelial Cervical Neoplasia 2
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
Dr. Jorge Sánchez-Lander Corresponding Author
Instituto de Oncología Dr. Luis Razetti, Caracas Venezuela
Phone: 582129870165
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place