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

Overview

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

Full Title of Study: “Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 – 4)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2019

Interventions

  • Procedure: Tumor biopsies
    • Tumor biopsies will be performed before and after treatment.
  • Procedure: Blood sampling
    • Blood sampling will be performed before and after treatment.

Arms, Groups and Cohorts

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Progression Free Survival evaluation
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: up to 24 months
    • Description of molecular tumor alterations regarding geographic location (country)

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Curie
  • Provider of Information About this Clinical Study
    • Sponsor

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