Detecting HPV-positive pelvic cancer relapses using blood tests
Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
This study is testing if blood tests can help find out if patients treated for HPV-related pelvic cancer have a relapse during their follow-up visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Locations | 5 sites (Besançon and 4 other locations) |
| Trial ID | NCT03739775 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients who have been treated for HPV-induced stage II or III invasive pelvic cancer and are currently in post-treatment follow-up. Participants will undergo blood sampling to detect circulating tumor DNA (ctDNA) at each hospital visit over a period of 30 months. Clinical, biological, and radiological data will be collected to monitor for any signs of cancer relapse. If a relapse occurs, follow-up will be discontinued, while those without relapse will continue to be monitored for an additional 6 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been curatively treated for HPV-induced pelvic cancer and have no evidence of invasive tumors.
Not a fit: Patients with active invasive tumors or those unable to participate in regular follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of cancer relapses, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA for cancer detection, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 1) Patient curatively treated within the past 3 years for: * a HPV-induced stage Ib3, Ic, II or III cervix cancer * a HPV-induced stage II or III anal canal, vagina, vulva or penis cancer 2. Patient with no evidence of any invasive tumor at inclusion (clinical and, if any, radiological exams). 3. Age ≥ 18 years 4. Availability of HPV genotyping of the treated cancer and/or archived tumor tissue available. 5. Patient who a follow-up visit is scheduled in the including center at least twice a year. 6. Patient being affiliated to the French social security. 7. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patient presenting with active invasive tumor masses (e.g. stage IV cancer). 2. Patient deprived from ability to decide on her own or placed under the authority of a tutor. 3. Patient unable to have a regular follow up for geographical, social or psychological reasons.
Where this trial is running
Besançon and 4 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- Institut Curie - Paris — Paris, France (Recruiting)
- Hôpital Tenon — Paris, France (Recruiting)
- CHU Pontchaillou — Rennes, France (Recruiting)
- Institut Curie - Saint-Cloud — Saint-Cloud, France (Recruiting)
Study contacts
- Principal investigator: François-Clément BIDARD, PhD — Institut Curie Paris
- Study coordinator: François-Clément BIDARD, PhD
- Email: francois-clement.bidard@curie.fr
- Phone: +33 (0)1 47 11 18 80
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.