Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)

NCT02428842 | Completed

• 1 other identifier: IC 2013-02 BIO-RAIDs
• Study Type: interventional
• Target: 419
• Locations: 5 countries
• Sites: 24

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.

Conditions

Cervical Cancer

Keywords

Cervical cancer; Tumor biopsies; Standard treatment; Molecular profile; Next Generation Sequencing

Outcome Measures

Primary Outcomes (1)

• Correlation between tumor biological profile and treatment response.

  Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.

  up to 6 months

Secondary Outcomes (4)

• Progression Free Survival evaluation

  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)

  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)

  up to 6 months

• Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)

  up to 24 months

Study Arms (1)

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.

Procedure: Tumor biopsies; Procedure: Blood sampling

Interventions

Tumor biopsies PROCEDURE

Tumor biopsies will be performed before and after treatment.

Tumor biopsies and blood sampling

Blood sampling PROCEDURE

Blood sampling will be performed before and after treatment.

Tumor biopsies and blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (24)

Institut de Cancérologie de l'Ouest - Paul Papin

Angers, 49933, France

Location

Institut Bergonié

Bordeaux, France

Location

Centre Hospitalier Intercommunal de Créteil - CHI Créteil

Créteil, 94010, France

Location

Centre Georges Francois Leclerc

Dijon, 21079, France

Location

Centre Léon Bérard

Lyon, France

Location

Institut Régional du Cancer de Montpellier - Val D'Aurelle

Montpellier, 34298, France

Location

Institut de Cancérologie de Lorraine - ICL

Nancy, France

Location

Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU

Nantes, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Insitut Curie

Paris, 75248, France

Location

Hôpital Tenon

Paris, France

Location

Institut René Huguenin

Saint-Cloud, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut de Cancérologie de Lorraine- ICL NANCY

Vandœuvre-lès-Nancy, 54519, France

Location

Institut de Cancerologie Gustave Roussy

Villejuif, 94805, France

Location

Groupe Hospitalier Bichat

Paris, Île-de-France Region, 75877, France

Location

Mhh Hanover - Hanover Medical School

Hanover, 30625, Germany

Location

Amsterdam Medical Center (AMC)

Amsterdam, Meibergdreef, 91105 AZ, Netherlands

Location

Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)

Amsterdam, 1006 BE, Netherlands

Location

Teo Health S.A. - Spitalul Sf. Constantin

Brasov, 500091, Romania

Location

Spitalul Clinic Municipal "Gavril Curteanu"

Oradea, 410469, Romania

Location

Clinica de radioterapie

Timișoara, 300041, Romania

Location

Clinic for operative oncology, Institute of oncology of Vojvodina

Kamenitz, 21204, Serbia

Location

Related Publications (2)

• 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.

  PMID: 38135059 DERIVED

• 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.

  PMID: 26531748 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: April 29, 2015
• Study Start: October 24, 2013
• Primary Completion: November 21, 2018
• Study Completion: October 20, 2020
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

DE (1); NL (2); FR (17); RO (3); SE (1)