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

NCT ID: NCT03739775

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2026-06-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Blood sampling

Group Type: OTHER

Blood sampling

Intervention Type: PROCEDURE

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

Interventions

Blood sampling

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François-Clément BIDARD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie Paris

Locations

CHU de Besançon

Besançon, , France

Institut Curie - Paris

Paris, , France

Hôpital Tenon

Paris, , France

CHU Pontchaillou

Rennes, , France

Institut Curie - Saint-Cloud

Saint-Cloud, , France

Countries

France

Other Identifiers

IC 2017-01

Identifier Type: -

Identifier Source: org_study_id