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

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ClinicalTrials.gov Identifier: NCT02428842
Recruitment Status : Active, not recruiting
First Posted : April 29, 2015
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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

Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: Tumor biopsies Procedure: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Study Start Date : July 2013
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428842


Locations
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France
Groupe Hospitalier Bichat
Paris, Ile De France, France, 75877
Institut de Cancérologie de l'Ouest - Paul Papin
Angers, France, 49933
Institut Bergonié
Bordeaux, France
Centre Hospitalier Intercommunal de Créteil - CHI Créteil
Créteil, France, 94010
Centre Georges Francois Leclerc
Dijon, France, 21079
Centre Léon Bérard
Lyon, France
Institut Régional du Cancer de Montpellier - Val D'Aurelle
Montpellier, France, 34298
Institut de Cancérologie de Lorraine - ICL
Nancy, France
Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU
Nantes, France
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Europeen Georges Pompidou
Paris, France, 75015
Insitut Curie
Paris, France, 75248
Hôpital Tenon
Paris, France
Institut René Huguenin
Saint-Cloud, France
Centre Paul Strauss
Strasbourg, France, 67065
Institut de Cancérologie de Lorraine- ICL NANCY
Vandœuvre-lès-Nancy, France, 54519
Institut de Cancerologie Gustave Roussy
Villejuif, France, 94805
Germany
Mhh Hanover - Hanover Medical School
Hannover, Germany, 30625
Netherlands
Amsterdam Medical Center (AMC)
Amsterdam, Meibergdreef, Netherlands, 91105 AZ
Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, Netherlands, 1006 BE
Romania
Teo Health S.A. - Spitalul Sf. Constantin
Brasov, Romania, 500091
Spitalul Clinic Municipal "Gavril Curteanu"
Oradea, Romania, 410469
Clinica de radioterapie
Timisoara, Romania, 300041
Serbia
Clinic for operative oncology, Institute of oncology of Vojvodina
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Institut Curie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02428842     History of Changes
Other Study ID Numbers: IC 2013-02 BIO-RAIDs
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Institut Curie:
Cervical cancer
Tumor biopsies
Standard treatment
Molecular profile
Next Generation Sequencing
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female