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

Institut Curie

Status: Active, not recruiting

Conditions: HPV Positive Pelvic Cancer

Treatments: Procedure: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT03739775

IC 2017-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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172 participants in 1 patient group

Blood sampling

Other group

Treatment:

Procedure: Blood sampling