Cervical CancerBIO-RAIDsNCT02428842
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
A study testing Tumor biopsies and Blood sampling in people with Cervical Cancer, run by Institut Curie at 24 sites in 5 countries.
Trial summary
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points. 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 biopsies and Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 24 Oct 2013to 20 Oct 2020
- 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
- No prior treatment for cervical cancer.
- FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
- Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage
- Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more).
- Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
- Age ≥ 18 years.
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- ECOG (Eastern Cooperative Oncology Group) 0-2.
- Life expectancy > 6 months.
- Patient eligible for standard treatment (according to standards of each center).
- Patient having health care insurance.
- Informed and signed consent by patient.
- (DICOM = Digital Imaging and Communications in Medicine)
Who cannot join
- Patient enrolled in a clinical trial involving an investigative new agent.
- Co morbidity, preventing patient to tolerate the proposed standard treatment.
- Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix).
- Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 .
- Patient deprived from ability to decide on her own.
- Patient unable to have a regular follow up for geographical, social or psychological reasons.
- Pregnancy or patient old enough to procreate and not using effective contraceptive method.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
France17 sites
Institut de Cancérologie de l'Ouest - Paul Papin
Angers, 49933
Institut Bergonié
Bordeaux
Centre Hospitalier Intercommunal de Créteil - CHI Créteil
Créteil, 94010
Centre Georges Francois Leclerc
Dijon, 21079
Centre Léon Bérard
Lyon
Institut Régional du Cancer de Montpellier - Val D'Aurelle
Montpellier, 34298
Institut de Cancérologie de Lorraine - ICL
Nancy
Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU
Nantes
Centre Antoine Lacassagne
Nice, 06189
Hopital Europeen Georges Pompidou
Paris, 75015
Insitut Curie
Paris, 75248
Hôpital Tenon
Paris
Groupe Hospitalier Bichat
Paris, Île-de-France Region, 75877
Institut René Huguenin
Saint-Cloud
Centre Paul Strauss
Strasbourg, 67065
Institut de Cancérologie de Lorraine- ICL NANCY
Vandœuvre-lès-Nancy, 54519
Institut de Cancerologie Gustave Roussy
Villejuif, 94805
Romania3 sites
Teo Health S.A. - Spitalul Sf. Constantin
Brasov, 500091
Spitalul Clinic Municipal "Gavril Curteanu"
Oradea, 410469
Clinica de radioterapie
Timișoara, 300041
Netherlands2 sites
Amsterdam Medical Center (AMC)
Amsterdam, Meibergdreef, 91105 AZ
Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, 1006 BE
Serbia1 site
Clinic for operative oncology, Institute of oncology of Vojvodina
Kamenitz, 21204
About this study
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.
- Conditions
- Cervical Cancer
- Being tested
- Tumor biopsies, Blood sampling
- Keywords
- Cervical cancer, Tumor biopsies, Standard treatment, Molecular profile, Next Generation Sequencing
- 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 biopsiesProcedure or surgery
Tumor biopsies will be performed before and after treatment.
Blood samplingProcedure or surgery
Blood sampling will be performed before and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Tumor biopsies and blood sampling | Other | Patient will undergo standard care with tumor and blood sampling before and after treatment.
Blood and tumor sampling will also be performed at disease progression/relapse. Receives: Procedure: Tumor biopsies; Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between tumor biological profile and treatment response.
Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.
Measured: up to 6 months
Secondary outcomes (4)
Progression Free Survival evaluation
Number of patient with no local/metastasis relapse 18 months after end of primary treatment course.
Measured: up to 18 months
Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country)
Description of primary treatment course regarding :
- Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline
- Geographic location(country)
Measured: up to six months
Standard treatment's side effects description (assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale - National Cancer Institute Common Toxicity Criteria for Adverse Effects)
Description of standard treatment's side effects will be assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale
Measured: up to 6 months
Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)
Description of molecular tumor alterations regarding geographic location (country)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start24 Oct 2013
- Primary completion21 Nov 2018
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 419 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
- NCT02428842
- Sponsor's protocol ID
- IC 2013-02 BIO-RAIDs
- Acronym
- BIO-RAIDs
- Status last verified
- Jan 2023
- First submitted
- 10 Feb 2015
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Chouchane-Mlik O, Oniga A, Latouche A, Halladjian M, Kleine-Borgmann FB, Gerardy JJ, Mittelbronn M, Kamal M, Scholl SM. Systematic assessment of tumor necrosis at baseline in cervical cancer - An independent factor associated with poor outcome. Hum Pathol. 2024 Jan;143:62-70. doi: 10.1016/j.humpath.2023.12.003. Epub 2023 Dec 20.
PubMed 38135059Ngo C, Samuels S, Bagrintseva K, Slocker A, Hupe P, Kenter G, Popovic M, Samet N, Tresca P, von der Leyen H, Deutsch E, Rouzier R, Belin L, Kamal M, Scholl S; RAIDs consortium http://www.raids-fp7.eu/. From prospective biobanking to precision medicine: BIO-RAIDs - an EU study protocol in cervical cancer. BMC Cancer. 2015 Nov 4;15:842. doi: 10.1186/s12885-015-1801-0.
PubMed 26531748
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
- ClinicalTrials.gov ID
- NCT02428842
- Acronym / sponsor ID
- BIO-RAIDs / IC 2013-02 BIO-RAIDs
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, Tumor biopsies, Standard treatment, Molecular profile, Next Generation Sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 24 Oct 2013 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 29 Apr 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.
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.
Study design
- Primary purpose
- Basic science
- 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 biopsies, Procedure: Blood samplingPatient will undergo standard care with tumor and blood sampling before and after treatment. Blood and tumor sampling will also be performed at disease progression/relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- No prior treatment for cervical cancer.
- FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
- Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage
- Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more).
- Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
Key exclusion criteria (7 listed)
- Patient enrolled in a clinical trial involving an investigative new agent.
- Co morbidity, preventing patient to tolerate the proposed standard treatment.
- Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix).
- Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 .
- Patient deprived from ability to decide on her own.
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 biopsiesTumor biopsies will be performed before and after treatment. | Procedure or surgery | Tumor biopsies and blood sampling |
| Blood samplingBlood sampling will be performed before and after treatment. | Procedure or surgery | Tumor biopsies and blood sampling |
Primary outcome
Correlation between tumor biological profile and treatment response.
Time frame: up to 6 months
Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.
4 secondary outcomes
Progression Free Survival evaluation
Time frame: up to 18 months
Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country)
Time frame: up to six months
Standard treatment's side effects description (assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale - National Cancer Institute Common Toxicity Criteria for Adverse Effects)
Time frame: up to 6 months
Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)
Time frame: up to 24 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 20 Jan 2023.
- Derived from this study: PubMed 38135059Chouchane-Mlik O, Oniga A, Latouche A, Halladjian M, Kleine-Borgmann FB, Gerardy JJ, Mittelbronn M, Kamal M, Scholl SM. Systematic assessment of tumor necrosis at baseline in cervical cancer - An independent factor associated with poor outcome. Hum Pathol. 2024 Jan;143:62-70. doi: 10.1016/j.humpath.2023.12.003. Epub 2023 Dec 20.
- Derived from this study: PubMed 26531748Ngo C, Samuels S, Bagrintseva K, Slocker A, Hupe P, Kenter G, Popovic M, Samet N, Tresca P, von der Leyen H, Deutsch E, Rouzier R, Belin L, Kamal M, Scholl S; RAIDs consortium http://www.raids-fp7.eu/. From prospective biobanking to precision medicine: BIO-RAIDs - an EU study protocol in cervical cancer. BMC Cancer. 2015 Nov 4;15:842. doi: 10.1186/s12885-015-1801-0.
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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.
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor biopsies and Blood sampling in people with Cervical Cancer, run by Institut Curie at 24 sites in 5 countries.
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 12 inclusion and 7 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, Romania, Netherlands, Germany, Serbia. 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?
Correlation between tumor biological profile and treatment response. (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428842, which also lists 2 linked publications.
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 20 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.