NCT03739775

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 24, 2019

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

7.4 years

First QC Date

November 9, 2018

Last Update Submit

September 12, 2025

Conditions

HPV Positive Pelvic Cancer

Keywords

HPV positive pelvic cancerCirculating tumor biomarker

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Positive predictive values of ctDNA.

    up to 36 months

  • Negative predictive values of ctDNA.

    up to 36 months

Study Arms (1)

Blood sampling

OTHER
Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

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

Blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Besançon

Besançon, 25030, France

Location

Institut Curie - Paris

Paris, 75005, France

Location

Hôpital Tenon

Paris, 75020, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Institut Curie - Saint-Cloud

Saint-Cloud, 92210, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • François-Clément BIDARD, PhD

    Institut Curie Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 14, 2018

Study Start

January 24, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
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).

Locations

FR(5)