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

Study Overview
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Brief Summary
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Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Tumor biopsies
* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tumor biopsies and blood sampling<br>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<br>* Tumor biopsies will be performed before and after treatment.<br>Procedure: Blood sampling<br>* Blood sampling will be performed before and after treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival evaluation | Number of patient with no local/metastasis relapse 18 months after end of primary treatment course. | 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) | 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 | 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) | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, Tumor biopsies, Standard treatment, Molecular profile, Next Generation Sequencing