Screening for anal cancer in women with vulvar lesions
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
This study is testing if screening for anal cancer with Pap smears can help women over 40 who have vulvar lesions catch any problems early and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03061435 on ClinicalTrials.gov |
What this trial studies
This study aims to screen women over the age of 40 who have high-grade vulvar dysplasia or vulvar cancer for anal cancer, which currently lacks established screening protocols. Participants will undergo anal Pap smears and, if abnormalities are detected, high-resolution anoscopy for further evaluation and treatment. The study is based on the premise that women with gynecological lesions are at increased risk for anal lesions and cancer. By identifying and treating anal cancer early, the study seeks to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and older with a previous diagnosis of high-grade vulvar dysplasia or vulvar cancer.
Not a fit: Patients who have a history of other cancers (except for basal cell carcinoma), are HIV positive, or are on immunosuppressant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early detection and treatment of anal cancer in women at high risk, potentially improving survival rates.
How similar studies have performed: While screening for anal cancer in this specific population is novel, previous studies have indicated a higher risk of anal lesions in women with gynecological cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women age ≥ 40 * Previous diagnosis of VIN 2/3 or vulvar Exclusion Criteria: * Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer * Women who are HIV positive * Women currently taking immunosuppressant medication * Women who have had a previous hysterectomy
Where this trial is running
Toronto, Ontario
- Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Danielle Vicus, MD — Odette Cancer Centre
- Study coordinator: Nithla Mohanathas, BSc
- Email: nithla.mohanathas@sunnybrook.ca
- Phone: 4164805000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.