blood sampling
ProcedurePatients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals.
NCT Number: NCT03739775
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU de Besançon, Besançon, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals.
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.
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)
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).
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).
Institut Curie
Other
Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
Acronym: CIRCA-HPV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.