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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739775
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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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.

Condition or disease Intervention/treatment Phase
HPV Positive Pelvic Cancer Procedure: Blood sampling Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : June 1, 2026
Estimated Study Completion Date : June 1, 2026
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: up to 36 months ]
    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.

  2. 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). [ Time Frame: up to 36 months ]
    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 :
  1. Positive predictive values of ctDNA. [ Time Frame: up to 36 months ]
    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).

  2. Negative predictive values of ctDNA. [ Time Frame: up to 36 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739775


Contacts
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Contact: François-Clément BIDARD, PhD +33 (0)1 47 11 18 80 francois-clement.bidard@curie.fr
Contact: Cyrine EZZILI +33(0)1 47 11 16 57 drci.promotion@curie.fr

Locations
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France
CHU de Besançon Recruiting
Besançon, France, 25030
Contact: Christophe BORG, MD         
Principal Investigator: Christophe BORG, MD         
Institut Curie - Paris Recruiting
Paris, France, 75005
Principal Investigator: Bruno BUECHER, MD         
Hôpital Tenon Recruiting
Paris, France, 75020
Principal Investigator: Florence HUGUET, MD         
CHU Pontchaillou Recruiting
Rennes, France, 35033
Principal Investigator: Astrid LIEVRE, PhD         
Institut Curie - Saint-Cloud Recruiting
Saint-Cloud, France, 92210
Principal Investigator: Nicolas POUGET, MD         
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: François-Clément BIDARD, PhD Institut Curie Paris
More Information
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03739775    
Other Study ID Numbers: IC 2017-01 CIRCA-HPV
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Supporting Materials: Statistical Analysis Plan (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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Curie:
HPV positive pelvic cancer
Circulating tumor biomarker
Additional relevant MeSH terms:
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Pelvic Neoplasms
Neoplasms by Site
Neoplasms