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

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: Tumor biopsies; Procedure: Blood sampling

• Registration Number: NCT02428842
• Lead Sponsor: Institut Curie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-24
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Primary Completion: 2018-11-21
• Study Completion: 2020-10-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 419

Inclusion Criteria

1. No prior treatment for cervical cancer.
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

1. Patient enrolled in a clinical trial involving an investigative new agent.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor biopsies and blood sampling	Tumor biopsies	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 and blood sampling	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.

Primary Outcome Measures

Name	Time	Method
Correlation between tumor biological profile and treatment response.	up to 6 months	Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival evaluation	up to 18 months	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)	up to six months	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)	up to 6 months	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)	up to 24 months	Description of molecular tumor alterations regarding geographic location (country)

Trial Locations

Locations (24)

Teo Health S.A. - Spitalul Sf. Constantin; 🇷🇴 Brasov, Romania

Clinic for operative oncology, Institute of oncology of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia

Spitalul Clinic Municipal "Gavril Curteanu"; 🇷🇴 Oradea, Romania

Clinica de radioterapie; 🇷🇴 Timisoara, Romania

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Insitut Curie; 🇫🇷 Paris, France

Centre Hospitalier Intercommunal de Créteil - CHI Créteil; 🇫🇷 Créteil, France

Groupe Hospitalier Bichat; 🇫🇷 Paris, Ile De France, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Institut de Cancérologie de Lorraine - ICL; 🇫🇷 Nancy, France

Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU; 🇫🇷 Nantes, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut René Huguenin; 🇫🇷 Saint-Cloud, France

Amsterdam Medical Center (AMC); 🇳🇱 Amsterdam, Meibergdreef, Netherlands

Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL); 🇳🇱 Amsterdam, Netherlands

Hôpital Tenon; 🇫🇷 Paris, France

Institut de Cancérologie de l'Ouest - Paul Papin; 🇫🇷 Angers, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

Institut de Cancerologie Gustave Roussy; 🇫🇷 Villejuif, France

Institut Régional du Cancer de Montpellier - Val D'Aurelle; 🇫🇷 Montpellier, France

Mhh Hanover - Hanover Medical School; 🇩🇪 Hannover, Germany

Institut de Cancérologie de Lorraine- ICL NANCY; 🇫🇷 Vandœuvre-lès-Nancy, France