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

• Sponsor: Institut Curie (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03739775
• Collaborator: (none)
• Enrollment: 172
• Locations: 5
• Arm: 1
• Anticipated Duration (Months): 88.2
• Patients Per Site: 34.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HPV Positive Pelvic Cancer	Procedure: Blood sampling	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 172 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
• Actual Study Start Date: Jan 24, 2019
• Anticipated Primary Completion Date: Jun 1, 2026
• Anticipated Study Completion Date: Jun 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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). [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.

2. 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). [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)

Secondary Outcome Measures

1. Positive predictive values of ctDNA. [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).

2. Negative predictive values of ctDNA. [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Patient with no evidence of any invasive tumor at inclusion (clinical and, if any, radiological exams).

2. Age ≥ 18 years

3. Availability of HPV genotyping of the treated cancer and/or archived tumor tissue available.

4. Patient who a follow-up visit is scheduled in the including center at least twice a year.

5. Patient being affiliated to the French social security.

6. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Besançon	Besançon		France	25030
2	Institut Curie - Paris	Paris		France	75005
3	Hôpital Tenon	Paris		France	75020
4	CHU Pontchaillou	Rennes		France	35033
5	Institut Curie - Saint-Cloud	Saint-Cloud		France	92210

Sponsors and Collaborators

• Institut Curie

Investigators

• Principal Investigator: François-Clément BIDARD, PhD, Institut Curie Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Curie
• ClinicalTrials.gov Identifier: NCT03739775
• Other Study ID Numbers: IC 2017-01 CIRCA-HPV
• First Posted: Nov 14, 2018
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut Curie: HPV positive pelvic cancer; Circulating tumor biomarker
• Additional relevant MeSH terms: Pelvic Neoplasms

Study Results

No Results Posted as of Jun 24, 2022