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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 January 2023
• Main ID: NCT02428842
• Date of registration: 10/02/2015
• Prospective Registration: No
• Primary sponsor: Institut Curie
• Public title: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4) BIO-RAIDs
• Scientific title: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
• Date of first enrolment: October 24, 2013
• Target sample size: 419
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02428842
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France, Germany, Netherlands, Romania, Serbia

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Procedure: Tumor biopsies

Procedure: Blood sampling

Primary Outcome(s)

Correlation between tumor biological profile and treatment response. [Time Frame: up to 6 months]

Secondary Outcome(s)

Progression Free Survival evaluation [Time Frame: up to 18 months]

Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country) [Time Frame: up to 24 months]

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]

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]

Secondary ID(s)

IC 2013-02 BIO-RAIDs

Source(s) of Monetary Support

Please refer to primary and secondary sponsors