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Trial record 1 of 268 for:    great | Ovary Cancer
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Genomic BRCA and Extensive ovArian Cancer Testing (GREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04027868
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Brief Summary:
This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

Condition or disease
Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Cohort Study to Evaluate the Clinical Features of Patients With Epithelial Ovarian Cancer Depending on Tumoral Mutation of BRCA or Beyond BRCA Genomic Molecular Abnormalities
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029





Primary Outcome Measures :
  1. Correlation between Progression Free Survival (PFS) and the detected tumor genetic abnormalities [ Time Frame: From baseline until the date of progression or death, which ever occurs earlier, assessed up to 10 years ]

Secondary Outcome Measures :
  1. Correlation between age and the detected tumor genetic abnormalities [ Time Frame: Baseline ]
  2. Correlation between histology status and the detected tumor genetic abnormalities [ Time Frame: Baseline ]
  3. Correlation between FIGO stage and the detected tumor genetic abnormalities [ Time Frame: Baseline ]
  4. Correlation between surgery resection status and the detected tumor genetic abnormalities [ Time Frame: Up to 10 years ]
  5. Correlation between treatment response and the detected tumor genetic abnormalities [ Time Frame: Up to 10 years ]
  6. Correlation between Overall survival (OS) and the detected tumor genetic abnormalities [ Time Frame: From baseline to death, assessed up to 10 years ]

Other Outcome Measures:
  1. Percentage of patients with both germinal and tumoral BRCA tests [ Time Frame: Up to 10 years ]
  2. Percentage of patients with a first germinal BRCA test, a first tumoral BRCA test, or simultaneous germinal and tumoral tests [ Time Frame: Up to 10 years ]
  3. Percentage of patients with and exploitable tumoral block for exploratory transversal researches [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
Tumor sample fixed in formalin and included in paraffin (FFPE)


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
Sampling Method:   Non-Probability Sample
Study Population
Patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014)
Criteria

Inclusion Criteria:

  • Patient older than 18 years.
  • Patient with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014)
  • Patient in first line therapy
  • Available tumor sample fixed in formalin and included in paraffin (FFPE):

    • in pre-chemotherapy, insofar as possible
    • having a sufficient tumor surface, with a final cellularity of at least 20%
  • Identification of a molecular genetics' cancer platform participant in GREAT and an onco-geneticists team working with the investigator team
  • Patient consenting her data to be collected and submitted through an automated processing
  • Patient beneficiary from the French social security

Exclusion Criteria:

  • Patient with a mucinous ovarian carcinoma
  • Patient pregnant or breastfeeding
  • Patient under legal protection (guardianship or court order) or unable to consent

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): NCT04027868


Contacts
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Contact: Aurelie Chabanon, PhD. +33184852036 achabanon@arcagy.org
Contact: Margaux Matos +33184852021 ext 01 mmatos@arcagy.org

Locations
Show Show 132 study locations
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
AstraZeneca
Investigators
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Principal Investigator: Thibault De La Motte Rouge, MD. Centre Eugène Marquis, Rennes
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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT04027868    
Other Study ID Numbers: GINECO-OV128
2019-A01190-57 ( Other Identifier: ANSM )
19.06.45 ( Other Identifier: Ethics Committee )
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ovarian Epithelial
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Fallopian Tube Diseases