Neoplasms

All Conditions

Pelvic Neoplasms

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

Blood sampling

François-Clément BIDARD, PhD

Cyrine EZZILI

Christophe BORG, MD

Bruno BUECHER, MD

Florence HUGUET, MD

Astrid LIEVRE, PhD

Nicolas POUGET, MD

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.

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

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

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.

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)

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).

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses	NCT03739775	HPV Positive Pe...	Blood sampling	18 Years -	Institut Curie
Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses	NCT03739775	HPV Positive Pe...	Blood sampling	18 Years -	Institut Curie
Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses	NCT03739775	HPV Positive Pe...	Blood sampling	18 Years -	Institut Curie

Spots Global Cancer Trial Database for hpv positive pelvic cancer