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

Last updated: September 12, 2025
Sponsor: Institut Curie
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pelvic Cancer

Treatment

Blood sampling

Clinical Study ID

NCT03739775
IC 2017-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    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

  1. Patient with no evidence of any invasive tumor at inclusion (clinical and, if any,radiological exams).

  2. Age ≥ 18 years

  3. Availability of HPV genotyping of the treated cancer and/or archived tumor tissueavailable.

  4. Patient who a follow-up visit is scheduled in the including center at least twice ayear.

  5. Patient being affiliated to the French social security.

  6. Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion

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 ofa tutor.

  3. Patient unable to have a regular follow up for geographical, social or psychologicalreasons.

Study Design

Total Participants: 172
Treatment Group(s): 1
Primary Treatment: Blood sampling
Phase:
Study Start date:
January 24, 2019
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • CHU de Besançon

    Besançon, 25030
    France

    Site Not Available

  • CHU de Besançon

    Besançon 3033123, 25030
    France

    Site Not Available

  • Hôpital Tenon

    Paris, 75020
    France

    Active - Recruiting

  • Institut Curie - Paris

    Paris, 75005
    France

    Site Not Available

  • Hôpital Tenon

    Paris 2988507, 75020
    France

    Site Not Available

  • Institut Curie - Paris

    Paris 2988507, 75005
    France

    Site Not Available

  • CHU Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • CHU Pontchaillou

    Rennes 2983990, 35033
    France

    Site Not Available

  • Institut Curie - Saint-Cloud

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut Curie - Saint-Cloud

    Saint-Cloud 2981041, 92210
    France

    Site Not Available

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