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

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.

Study Overview

• Status: Recruiting
• Conditions: HPV Positive Pelvic Cancer
• Intervention / Treatment: Procedure: Blood sampling

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.

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François-Clément BIDARD, PhD; Phone Number: +33 (0)1 47 11 18 80; Email: francois-clement.bidard@curie.fr
• Study Contact Backup: Name: Cyrine EZZILI; Phone Number: +33(0)1 47 11 16 57; Email: drci.promotion@curie.fr

Study Locations

• France
  • Besançon, France, 25030
    • Recruiting
    • CHU de Besancon
    • Principal Investigator: Christophe BORG, MD
    • Contact: Christophe BORG, MD
  • Paris, France, 75020
    • Recruiting
    • Hôpital Tenon
    • Principal Investigator: Florence HUGUET, MD
  • Paris, France, 75005
    • Recruiting
    • Institut Curie - Paris
    • Principal Investigator: Bruno BUECHER, MD
  • Rennes, France, 35033
    • Recruiting
    • CHU Pontchaillou
    • Principal Investigator: Astrid LIEVRE, PhD
  • Saint-Cloud, France, 92210
    • Recruiting
    • Institut Curie - Saint-Cloud
    • Principal Investigator: Nicolas POUGET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood sampling	Procedure: Blood sampling; Patients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of plasma circulating tumor DNA detection as a test to detect any (local or distant) relapse in patients who have been curatively treated for HPV-induced invasive pelvic cancer (cervix, anal canal, vagina, vulva, penis).	Sensitivity= % of patients with number of copies/ml of ctDNA > threshold among those who experience a relapse within 6 months (+14 days) after the blood draw.	up to 36 months
Specificity of plasma circulating tumor DNA detection as a test to detect any (local or distant) relapse in patients who have been curatively treated for HPV-induced invasive pelvic cancer (cervix, anal canal, vagina, vulva, penis).	Specificity= % of patients with number of copies/ml of ctDNA < threshold among those who don't experience a relapse within the 6 months after the blood draw (+14 days)	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive values of ctDNA.	Positive Predictive Value= Probability of being diagnosed with a relapse within 6 months (+14 days) after positive testing (number of copies of ctDNA in the plasma > threshold).	up to 36 months
Negative predictive values of ctDNA.	Negative Predictive Value= Probability of being relapse-free during the 6 months (+14 days) after negative testing (number of copies of ctDNA in the plasma < threshold).	up to 36 months

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: François-Clément BIDARD, PhD, Institut Curie Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HPV positive pelvic cancer; Circulating tumor biomarker
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pelvic Neoplasms
• Other Study ID Numbers: IC 2017-01 CIRCA-HPV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No