HPV Positive Pelvic CancerCIRCA-HPVNCT03739775
Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses (CIRCA-HPV)
A study testing Blood sampling in people with HPV Positive Pelvic Cancer, run by Institut Curie at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV Positive Pelvic Cancer
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 5 sitesFrance
- Study dates
- 24 Jan 2019to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
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- 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.
Who cannot join
- Patient presenting with active invasive tumor masses (e.g. stage IV cancer).
- Patient deprived from ability to decide on her own or placed under the authority of a tutor.
- Patient unable to have a regular follow up for geographical, social or psychological reasons.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Besançon
Besançon, 25030
Institut Curie - Paris
Paris, 75005
Hôpital Tenon
Paris, 75020
CHU Pontchaillou
Rennes, 35033
Institut Curie - Saint-Cloud
Saint-Cloud, 92210
About this study
Official title: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
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.
Read the 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.
- Conditions
- HPV Positive Pelvic Cancer
- Being tested
- Blood sampling
- Keywords
- HPV positive pelvic cancer, Circulating tumor biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Patients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals.
| Study group | Role | What they receive |
|---|---|---|
| Blood sampling | Other | Not described Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: up to 36 months
Secondary outcomes (2)
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).
Measured: up to 36 months
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).
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start24 Jan 2019
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV Positive Pelvic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Clément BIDARD, PhD, Principal investigator, Institut Curie Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739775
- Sponsor's protocol ID
- IC 2017-01
- Acronym
- CIRCA-HPV
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2018
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
- ClinicalTrials.gov ID
- NCT03739775
- Acronym / sponsor ID
- CIRCA-HPV / IC 2017-01
- Conditions
- HPV Positive Pelvic Cancer
- Keywords
- HPV positive pelvic cancer, Circulating tumor biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sampling | Other | Procedure: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient presenting with active invasive tumor masses (e.g. stage IV cancer).
- Patient deprived from ability to decide on her own or placed under the authority of a tutor.
- Patient unable to have a regular follow up for geographical, social or psychological reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingPatients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals. | Procedure or surgery | Blood sampling |
Primary outcome
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).
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.
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).
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)
2 secondary outcomes
Positive predictive values of ctDNA.
Time frame: up to 36 months
Negative predictive values of ctDNA.
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Related trials for HPV Positive Pelvic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François-Clément BIDARD, PhD principal investigator
Institut Curie Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with HPV Positive Pelvic Cancer, run by Institut Curie at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.