Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02428842
NCT02428842CompletedNot Applicable

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

Institut Curie42 sites in 5 countries419 target enrollmentStarted: October 24, 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
419
Locations
42
Primary Endpoint
Correlation between tumor biological profile and treatment response.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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 ≥ IB
  • •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-
  • •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.

Outcomes

Primary Outcomes

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

  • Progression Free Survival evaluation(up to 18 months)
  • Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country)(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)(up to 6 months)
  • Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)(up to 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (42)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Biomarker evaluation in advanced stage cervical cancer by an international working group. Tumor Stages (1B1-4).cervical carcinoma10038594Cervical cancer
NL-OMON41533Institut Curie100
Completed
Not Applicable
Development and evaluation of a cervical cancer screening training program for midwives in Japacervical cancer
JPRN-UMIN000044260Japanese Red Cross Medical Center206
Completed
Not Applicable
Data survey of patients with early cervical carcinoma after trachelectomy, who want to have childrecervix carcinomaC53Malignant neoplasm of cervix uteri
DRKS00012380Forschungsinstitut für FrauengesundheitDepartment für Frauengesundheit30
Unknown
Not Applicable
SUCCOR-Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical CancerUterine Cervical Neoplasms
NCT03958305Clinica Universidad de Navarra, Universidad de Navarra1,000
Recruiting
Not Applicable
Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical CarcinomaUterine Cervical Neoplasm
NCT06560697National Institute of Cancerología84