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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood sampling | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Patients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals. |
|
| 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 |
| 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. |
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Inclusion Criteria:
1) Patient curatively treated within the past 3 years for:
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:
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| Name | Affiliation | Role |
|---|---|---|
| François-Clément BIDARD, PhD | Institut Curie Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | 25030 | France | |||
| Institut Curie - Paris |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
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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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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 |
| Paris |
| 75005 |
| France |
| Hôpital Tenon | Paris | 75020 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| Institut Curie - Saint-Cloud | Saint-Cloud | 92210 | France |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |