Clinical trial NCT03739775: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
Official title: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Positive Pelvic Cancer
Keywords: HPV positive pelvic cancer
Circulating tumor biomarker
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: up to 36 months
measure: 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).
timeFrame: up to 36 months
Secondary outcomes:
measure: Positive predictive values of ctDNA.
timeFrame: up to 36 months
measure: Negative predictive values of ctDNA.
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Paris
country: France
facility: Institut Curie - Paris
city: Paris
country: France
facility: Hôpital Tenon
city: Rennes
country: France
facility: CHU Pontchaillou
city: Saint-Cloud
country: France
facility: Institut Curie - Saint-Cloud
Study officials:
affiliation: Institut Curie Paris
name: François-Clément BIDARD, PhD
role: PRINCIPAL_INVESTIGATOR
References: