Clinical trial · Interventional
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer
NCT02140021CI-TRIAL-00092065terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.
Conditions
Conditions (55)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenocarcinoma In Situ | Cervical Adenocarcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Cervical Squamous Intraepithelial Neoplasia | Cervical Squamous Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Early Invasive Cervical Adenocarcinoma | Early Invasive Cervical Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Early Invasive Cervical Squamous Cell Carcinoma | Microinvasive Cervical Squamous Cell Carcinoma | ALIAS | 0.90 |
| High Grade Cervical Squamous Intraepithelial Neoplasia |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (biospecimen collection)
- description
- Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Laboratory Biomarker Analysis
Primary outcomes (4)
- measure
- Prevalence of invasive squamous cell carcinoma of the anus
- timeFrame
- Up to 5 years
- description
- Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals.
- measure
- Sensitivity and specificity of anal pap testing to diagnose anal dysplasia
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with histologically confirmed cervical, vaginal or vulvar high-grade dysplasia, invasive squamous cell carcinoma, invasive adenocarcinoma, or adenocarcinoma-in-situ (AIS). All stages and grades will be eligible. * Women with a diagnosis of high grade intraepithelial lesion (HSIL) from a routine pap test. * Patients must sign an approved informed consent document. Exclusion Criteria: * Patients with previously documented perianal squamous cell dysplasia or invasive squamous cell carcinoma of the anus or anal canal. * Patients unwilling or unable to provide informed consent for the study. * Male patients will not be included in this study. * Patients with previously documented HPV related oropharyngeal cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.