Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer
| Verified date | April 2024 |
| Source | M.D. Anderson Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 409 |
| Est. completion date | April 30, 2026 |
| Est. primary completion date | April 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lyndon Baines Johnson General Hospital | Houston | Texas |
| United States | M D Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of invasive squamous cell carcinoma of the anus | Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals. | Up to 5 years | |
| Primary | Sensitivity and specificity of anal pap testing to diagnose anal dysplasia | Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals. | Up to 5 years | |
| Primary | Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia | Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals. | Up to 5 years | |
| Primary | Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia | Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals. | Up to 5 years |
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|---|---|---|---|
| Active, not recruiting |
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