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

Primary Purpose

HPV Positive Pelvic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sampling

About this trial

This is an interventional diagnostic trial for HPV Positive Pelvic Cancer focused on measuring HPV positive pelvic cancer, Circulating tumor biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Patient with no evidence of any invasive tumor at inclusion (clinical and, if any, radiological exams).
Age ≥ 18 years
Availability of HPV genotyping of the treated cancer and/or archived tumor tissue available.
Patient who a follow-up visit is scheduled in the including center at least twice a year.
Patient being affiliated to the French social security.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patient presenting with active invasive tumor masses (e.g. stage IV cancer).
Patient deprived from ability to decide on her own or placed under the authority of a tutor.
Patient unable to have a regular follow up for geographical, social or psychological reasons.

Sites / Locations

CHU de BesançonRecruiting
Institut Curie - ParisRecruiting
Hôpital TenonRecruiting
CHU PontchaillouRecruiting
Institut Curie - Saint-CloudRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Blood sampling

Arm Description

Outcomes

Primary Outcome Measures

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.

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)

Secondary Outcome Measures

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).

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).

Full Information

NCT ID

NCT03739775

First Posted

November 9, 2018

Last Updated

June 21, 2022

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT03739775

Brief Title

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

Acronym

CIRCA-HPV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 24, 2019 (Actual)

Primary Completion Date

June 1, 2026 (Anticipated)

Study Completion Date

June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV Positive Pelvic Cancer

Keywords

HPV positive pelvic cancer, Circulating tumor biomarker

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blood sampling

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

Blood sampling

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

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.

Time Frame

up to 36 months

Title

Description

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)

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Positive predictive values of ctDNA.

Description

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).

Time Frame

up to 36 months

Title

Negative predictive values of ctDNA.

Description

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).

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Patient with no evidence of any invasive tumor at inclusion (clinical and, if any, radiological exams). Age ≥ 18 years Availability of HPV genotyping of the treated cancer and/or archived tumor tissue available. Patient who a follow-up visit is scheduled in the including center at least twice a year. Patient being affiliated to the French social security. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patient presenting with active invasive tumor masses (e.g. stage IV cancer). Patient deprived from ability to decide on her own or placed under the authority of a tutor. Patient unable to have a regular follow up for geographical, social or psychological reasons.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

François-Clément BIDARD, PhD

Phone

+33 (0)1 47 11 18 80

francois-clement.bidard@curie.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Cyrine EZZILI

Phone

+33(0)1 47 11 16 57

drci.promotion@curie.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

François-Clément BIDARD, PhD

Organizational Affiliation

Institut Curie Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Besançon

City

Besançon

ZIP/Postal Code

25030

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christophe BORG, MD

First Name & Middle Initial & Last Name & Degree

Christophe BORG, MD

Facility Name

Institut Curie - Paris

City

Paris

ZIP/Postal Code

75005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno BUECHER, MD

Facility Name

Hôpital Tenon

City

Paris

ZIP/Postal Code

75020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florence HUGUET, MD

Facility Name

CHU Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Astrid LIEVRE, PhD

Facility Name

Institut Curie - Saint-Cloud

City

Saint-Cloud

ZIP/Postal Code

92210

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas POUGET, MD

12. IPD Sharing Statement

Learn more about this trial

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

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