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

Institut Curie

Status: Completed

Conditions: Cervical Cancer

Treatments: Procedure: Tumor biopsies; Procedure: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02428842

IC 2013-02 BIO-RAIDs

Details and patient eligibility

About

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

Enrollment: 419 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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419 participants in 1 patient group

Tumor biopsies and blood sampling

Other group

Description:

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.

Treatment:

Procedure: Tumor biopsies

Procedure: Blood sampling