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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HPV Positive Pelvic Cancer

Intervention / Treatment
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* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV positive pelvic cancer, Circulating tumor biomarker