Status:
COMPLETED
Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
18+ years
Brief Summary
RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of c...
Detailed Description
OBJECTIVES: * Utilize molecular assays to identify a panel of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer (ICC) among pat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:
- Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:
- CIN grade 2-3 or higher
- Repeated CIN1 (times 6)
- Abnormal Pap smear (atypical squamous cells of undetermined significance \[ASCUS\] or worse)
- HIV seropositive
- Negative cytology but positive for high-risk human papillomavirus (HPV)
- Negative cytology and negative HPV
- HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)
- \>= 18 years of age
- Intact cervix
- Not pregnant
- Able to provide informed consent
- EXCLUSION CRITERIA:
- \< 18 years of age
- Pregnant at screening
- Cervix not intact
- not able to provide informed consent
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
1680 Patients enrolled
Trial Details
Trial ID
NCT00458562
Start Date
January 1 2006
End Date
November 1 2012
Last Update
November 19 2013
Active Locations (2)
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1
Centre Hospitalier Universite De Fann
Dakar, Senegal, BP 5035
2
Hopital Aristide Le Dantec
Dakar, Senegal, BP 5126