Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
NCT ID: NCT02428842
Last Updated: 2023-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
419 participants
INTERVENTIONAL
2013-10-24
2020-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Tumor biopsies and blood sampling
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.
Tumor biopsies
Tumor biopsies will be performed before and after treatment.
Blood sampling
Blood sampling will be performed before and after treatment.
Interventions
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Tumor biopsies
Tumor biopsies will be performed before and after treatment.
Blood sampling
Blood sampling will be performed before and after treatment.
Eligibility Criteria
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Inclusion Criteria
2. FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
3. Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage
4. Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more).
5. Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
6. Age ≥ 18 years.
7. ECOG (Eastern Cooperative Oncology Group) 0-2.
8. Life expectancy \> 6 months.
9. Patient eligible for standard treatment (according to standards of each center).
10. Patient having health care insurance.
11. Informed and signed consent by patient.
(DICOM = Digital Imaging and Communications in Medicine)
Exclusion Criteria
2. Co morbidity, preventing patient to tolerate the proposed standard treatment.
3. 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).
4. Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 .
5. Patient deprived from ability to decide on her own.
6. Patient unable to have a regular follow up for geographical, social or psychological reasons.
7. Pregnancy or patient old enough to procreate and not using effective contraceptive method.
18 Years
FEMALE
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Locations
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Institut de Cancérologie de l'Ouest - Paul Papin
Angers, , France
Institut Bergonié
Bordeaux, , France
Centre Hospitalier Intercommunal de Créteil - CHI Créteil
Créteil, , France
Centre Georges Francois Leclerc
Dijon, , France
Centre Léon Bérard
Lyon, , France
Institut Régional du Cancer de Montpellier - Val D'Aurelle
Montpellier, , France
Institut de Cancérologie de Lorraine - ICL
Nancy, , France
Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Europeen Georges Pompidou
Paris, , France
Insitut Curie
Paris, , France
Hôpital Tenon
Paris, , France
Institut René Huguenin
Saint-Cloud, , France
Centre Paul Strauss
Strasbourg, , France
Institut de Cancérologie de Lorraine- ICL NANCY
Vandœuvre-lès-Nancy, , France
Institut de Cancerologie Gustave Roussy
Villejuif, , France
Groupe Hospitalier Bichat
Paris, Île-de-France Region, France
Mhh Hanover - Hanover Medical School
Hanover, , Germany
Amsterdam Medical Center (AMC)
Amsterdam, Meibergdreef, Netherlands
Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, , Netherlands
Teo Health S.A. - Spitalul Sf. Constantin
Brasov, , Romania
Spitalul Clinic Municipal "Gavril Curteanu"
Oradea, , Romania
Clinica de radioterapie
Timișoara, , Romania
Clinic for operative oncology, Institute of oncology of Vojvodina
Kamenitz, , Serbia
Countries
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References
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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.
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.
Other Identifiers
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IC 2013-02 BIO-RAIDs
Identifier Type: -
Identifier Source: org_study_id
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