NCT03061435 Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
| NCT ID | NCT03061435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Danielle Vicus |
| Condition | Vulvar Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2021-02-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population. Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.
Eligibility 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
Contact & Investigator
Danielle Vicus, MD
PRINCIPAL INVESTIGATOR
Odette Cancer Centre
Frequently Asked Questions
Who can join the NCT03061435 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Vulvar Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03061435 currently recruiting?
Yes, NCT03061435 is actively recruiting participants. Contact the research team at nithla.mohanathas@sunnybrook.ca for enrollment information.
Where is the NCT03061435 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT03061435 clinical trial?
NCT03061435 is sponsored by Dr. Danielle Vicus. The principal investigator is Danielle Vicus, MD at Odette Cancer Centre. The trial plans to enroll 110 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.