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

HPV Positive Pelvic Cancer Clinical Trial

— CIRCA-HPV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03739775
• Other study ID #: IC 2017-01 CIRCA-HPV
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: June 1, 2026

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: François-Clément BIDARD, PhD
• Phone: +33 (0)1 47 11 18 80
• Email: francois-clement.bidard[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HPV Positive Pelvic Cancer
• Pelvic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Hôpital Tenon	Paris
France	Institut Curie - Paris	Paris
France	CHU Pontchaillou	Rennes
France	Institut Curie - Saint-Cloud	Saint-Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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