NCT03739775

Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses (CIRCA-HPV)

Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ctDNA detection in patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up.

Detailed description

Patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up will be included. These patients will be followed up during 30 months (2.5 years) (if no relapse occurred before) with ctDNA detection performed at each hospital visit. At each visit, clinical, biological (squamous cell carcinoma (SCC) serum marker will be done systematically) and radiological/pathology (if any) results will be prospectively collected in the study. For the patients who have a relapse or new HPV-induced invasive cancer before 30 months, the follow-up will be discontinued at the date of the relapse. For the patients who will have completed their follow-up for the study (2.5 years) with no relapse or new HPV-induced invasive cancer, they will be followed up for 6 months (+ 14 days), to collect any late relapse (if any). None specific study procedure will be performed during this period.

Conditions

• HPV Positive Pelvic Cancer

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	Patients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals.

Timeline

• Start date: 2019-01-24
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2018-11-14
• Last updated: 2025-09-15

Locations

5 sites across 1 country: France