Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4) (BIO-RAIDs)
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tumor biopsies
Blood sampling
Sponsored by
About this trial
This is an interventional basic science trial for Cervical Cancer focused on measuring Cervical cancer, Tumor biopsies, Standard treatment, Molecular profile, Next Generation Sequencing
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Groupe Hospitalier Bichat
- Institut de Cancérologie de l'Ouest - Paul Papin
- Institut Bergonié
- Centre Hospitalier Intercommunal de Créteil - CHI Créteil
- Centre Georges Francois Leclerc
- Centre Léon Bérard
- Institut Régional du Cancer de Montpellier - Val D'Aurelle
- Institut de Cancérologie de Lorraine - ICL
- Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU
- Centre Antoine Lacassagne
- Hopital Europeen Georges Pompidou
- Insitut Curie
- Hôpital Tenon
- Institut René Huguenin
- Centre Paul Strauss
- Institut de Cancérologie de Lorraine- ICL NANCY
- Institut de Cancerologie Gustave Roussy
- Mhh Hanover - Hanover Medical School
- Amsterdam Medical Center (AMC)
- Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)
- Teo Health S.A. - Spitalul Sf. Constantin
- Spitalul Clinic Municipal "Gavril Curteanu"
- Clinica de radioterapie
- Clinic for operative oncology, Institute of oncology of Vojvodina
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tumor biopsies and blood sampling
Arm Description
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.
Outcomes
Primary Outcome Measures
Correlation between tumor biological profile and treatment response.
Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.
Secondary Outcome Measures
Progression Free Survival evaluation
Number of patient with no local/metastasis relapse 18 months after end of primary treatment course.
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)
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
Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)
Description of molecular tumor alterations regarding geographic location (country)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02428842
Brief Title
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Acronym
BIO-RAIDs
Official Title
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 24, 2013 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
October 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer, Tumor biopsies, Standard treatment, Molecular profile, Next Generation Sequencing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
419 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tumor biopsies and blood sampling
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tumor biopsies
Intervention Description
Tumor biopsies will be performed before and after treatment.
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling will be performed before and after treatment.
Primary Outcome Measure Information:
Title
Correlation between tumor biological profile and treatment response.
Description
Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Progression Free Survival evaluation
Description
Number of patient with no local/metastasis relapse 18 months after end of primary treatment course.
Time Frame
up to 18 months
Title
Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country)
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
Title
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
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
Time Frame
up to 6 months
Title
Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)
Description
Description of molecular tumor alterations regarding geographic location (country)
Time Frame
up to 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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)
Exclusion Criteria:
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.
Facility Information:
Facility Name
Groupe Hospitalier Bichat
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75877
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil - CHI Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Institut Régional du Cancer de Montpellier - Val D'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut de Cancérologie de Lorraine - ICL
City
Nancy
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU
City
Nantes
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Insitut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hôpital Tenon
City
Paris
Country
France
Facility Name
Institut René Huguenin
City
Saint-Cloud
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut de Cancérologie de Lorraine- ICL NANCY
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Institut de Cancerologie Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Mhh Hanover - Hanover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Amsterdam Medical Center (AMC)
City
Amsterdam
State/Province
Meibergdreef
ZIP/Postal Code
91105 AZ
Country
Netherlands
Facility Name
Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)
City
Amsterdam
ZIP/Postal Code
1006 BE
Country
Netherlands
Facility Name
Teo Health S.A. - Spitalul Sf. Constantin
City
Brasov
ZIP/Postal Code
500091
Country
Romania
Facility Name
Spitalul Clinic Municipal "Gavril Curteanu"
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Clinica de radioterapie
City
Timisoara
ZIP/Postal Code
300041
Country
Romania
Facility Name
Clinic for operative oncology, Institute of oncology of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
12. IPD Sharing Statement
Citations:
PubMed Identifier
26531748
Citation
Ngo 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.
Results Reference
derived
Learn more about this trial
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
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