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Completed

NCT Number: NCT02428842

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Bichat, Paris, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumor biopsies

Procedure

Tumor biopsies will be performed before and after treatment.

blood sampling

Procedure

Blood sampling will be performed before and after treatment.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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)
  3. 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

  4. 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)

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: BIO-RAIDs

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Apr 29, 2015
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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