Cervical CancerPAIR HPVNCT02554565
Innovation for Standard Identification of Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cancer: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV)
A study testing Tumor biopsy and Blood sampling in people with Cervical Cancer, run by Institut Curie at 4 sites in France.
Trial summary
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Tumor biopsy and Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesFrance
- Study dates
- 29 Jul 2014to 27 Sep 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with cervical cancer, at any stage, before any anti-tumoral treatment.
- Age ≥ 18 years.
- Patient information and signature of the informed consent or her/his legal representative.
- Patient having given her/his agreement for a second biopsy at diagnosis if the first one was performed outside of the center and was not cryopreserved.
Who cannot join
- Person deprived of liberty or under supervision.
- Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Besançon
Besançon, 25000
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63000
Institut Curie
Paris, 75005
About this study
Official title: Innovation for Standard Identification for Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cance: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV : Human PapillomaVirus)
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
Read the detailed description
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
- Conditions
- Cervical Cancer
- Being tested
- Tumor biopsy, Blood sampling
- Keywords
- Patients with cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyProcedure or surgery
Tumor biopsy before treatment
Blood samplingProcedure or surgery
Blood sample before, during and after treatment
| Study group | Role | What they receive |
|---|---|---|
| Tumor biopsies and blood sampling | Other | Not described Receives: Procedure: Tumor biopsy; Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
Detection rate of circulating tumoral DNA with confidence interval of 95% of this rate.
Description of the variability of this rate according to the initial stage of the disease, treatment and disease progression.
Measured: Until 2 years after treatment
Secondary outcomes (2)
Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences.
Correlation between the two PCR/NGS detection methods - appreciation of the NGS method sensitivity compared to the PCR.
Measured: Until 2 years after treatment
Detailed molecular characterization of genes alterations implicated in cervical oncogenesis.
The characterization of HPV types and HPV integration sites as well as the sequencing of representative panel of genes involved in the tumorigenesis pattway.
Measured: Until 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start29 Jul 2014
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Why it stopped: Study in competition with another so it was decided to stop recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554565
- Sponsor's protocol ID
- IC 2013-06
- Acronym
- PAIR HPV
- Status last verified
- Mar 2019
- First submitted
- 1 Jul 2015
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation for Standard Identification for Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cance: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV : Human PapillomaVirus)
- ClinicalTrials.gov ID
- NCT02554565
- Acronym / sponsor ID
- PAIR HPV / IC 2013-06
- Conditions
- Cervical Cancer
- Keywords
- Patients with cervical cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study in competition with another so it was decided to stop recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 29 Jul 2014 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
Detailed description
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor biopsies and blood sampling | Other | Procedure: Tumor biopsy, Procedure: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with cervical cancer, at any stage, before any anti-tumoral treatment.
- Age ≥ 18 years.
- Patient information and signature of the informed consent or her/his legal representative.
- Patient having given her/his agreement for a second biopsy at diagnosis if the first one was performed outside of the center and was not cryopreserved.
Key exclusion criteria (2 listed)
- Person deprived of liberty or under supervision.
- Inability to attend scheduled follow-up visits for any psychological, sociological or geographical 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 |
|---|---|---|
| Tumor biopsyTumor biopsy before treatment | Procedure or surgery | Tumor biopsies and blood sampling |
| Blood samplingBlood sample before, during and after treatment | Procedure or surgery | Tumor biopsies and blood sampling |
Primary outcome
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
Time frame: Until 2 years after treatment
Detection rate of circulating tumoral DNA with confidence interval of 95% of this rate. Description of the variability of this rate according to the initial stage of the disease, treatment and disease progression.
2 secondary outcomes
Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences.
Time frame: Until 2 years after treatment
Detailed molecular characterization of genes alterations implicated in cervical oncogenesis.
Time frame: Until 2 years after treatment
Results and safety
The study was stopped early (reason given: Study in competition with another so it was decided to stop recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor biopsy and Blood sampling in people with Cervical Cancer, run by Institut Curie at 4 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Study in competition with another so it was decided to stop recruitment). Results are not available in the source record.
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?
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease. (time frame: Until 2 years after treatment). 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 8 Sep 2025.