Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers

NCT ID: NCT03976999

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2032-07-31

Brief Summary

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A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.

Detailed Description

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A Clinical and Biological Database is a collection of reliable, prospective and representative datas.

This collection, provided to the scientific community, will help to develope research programs such as :

* Cinicals and biological predictive factors of treatments response
* Identification of biological tumoral markers associate with survival
* Identification of prognosic factors after recidivism
* Diagnostics tests optimisation and follow-up from blood samples ( Circulating Tumor Cells (CTC) )
* Developing strong preclinical models. Those models would be later used to test alternative treatments and would help to identify new biomarkers

Conditions

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Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Peritoneal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Biological collection

For all the patients include in the studie :

* Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
* Tissue samples (tumor tissue and healthy tissue) collected during the surgery

In parallel to this biological collection, standardized clinical data will be entered into a database

Group Type EXPERIMENTAL

Biological collection

Intervention Type OTHER

* Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
* Tissue samples (tumor tissue and healthy tissue) collected during the surgery

Interventions

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Biological collection

* Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
* Tissue samples (tumor tissue and healthy tissue) collected during the surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 or older
* Patient at the diagnosis of an epithelial ovarian cancer, or a fallopian tube caner or a primitive peritoneal cancer
* Patient eligible for, at least, one surgery and a chemotherapy
* Patient having given his informed, written and express consent

Exclusion Criteria

* Patient not affiliated to a social protection scheme
* Pregnant and / or nursing women
* Subject under tutelage, curatorship or safeguard of justice
* Patient whose regular follow-up is impossible for psychological, familial, social or geographical reasons
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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COLOMBO Pierre-Emmanuel, M.D

Role: PRINCIPAL_INVESTIGATOR

ICM - Institut régional du Cancer Montpellier

Locations

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ICM - Institut régional du Cancer Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aurore MOUSSION

Role: CONTACT

+33 4 67 61 31 02

Facility Contacts

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BLEUSE Jean-Pierre, MD

Role: primary

0467613102 ext. +33

References

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Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.

Reference Type RESULT
PMID: 26742998 (View on PubMed)

Bolton KL, Chenevix-Trench G, Goh C, Sadetzki S, Ramus SJ, Karlan BY, Lambrechts D, Despierre E, Barrowdale D, McGuffog L, Healey S, Easton DF, Sinilnikova O, Benitez J, Garcia MJ, Neuhausen S, Gail MH, Hartge P, Peock S, Frost D, Evans DG, Eeles R, Godwin AK, Daly MB, Kwong A, Ma ES, Lazaro C, Blanco I, Montagna M, D'Andrea E, Nicoletto MO, Johnatty SE, Kjaer SK, Jensen A, Hogdall E, Goode EL, Fridley BL, Loud JT, Greene MH, Mai PL, Chetrit A, Lubin F, Hirsh-Yechezkel G, Glendon G, Andrulis IL, Toland AE, Senter L, Gore ME, Gourley C, Michie CO, Song H, Tyrer J, Whittemore AS, McGuire V, Sieh W, Kristoffersson U, Olsson H, Borg A, Levine DA, Steele L, Beattie MS, Chan S, Nussbaum RL, Moysich KB, Gross J, Cass I, Walsh C, Li AJ, Leuchter R, Gordon O, Garcia-Closas M, Gayther SA, Chanock SJ, Antoniou AC, Pharoah PD; EMBRACE; kConFab Investigators; Cancer Genome Atlas Research Network. Association between BRCA1 and BRCA2 mutations and survival in women with invasive epithelial ovarian cancer. JAMA. 2012 Jan 25;307(4):382-90. doi: 10.1001/jama.2012.20.

Reference Type RESULT
PMID: 22274685 (View on PubMed)

Colombo PE, Fabbro M, Theillet C, Bibeau F, Rouanet P, Ray-Coquard I. Sensitivity and resistance to treatment in the primary management of epithelial ovarian cancer. Crit Rev Oncol Hematol. 2014 Feb;89(2):207-16. doi: 10.1016/j.critrevonc.2013.08.017. Epub 2013 Sep 8.

Reference Type RESULT
PMID: 24071502 (View on PubMed)

Yang D, Khan S, Sun Y, Hess K, Shmulevich I, Sood AK, Zhang W. Association of BRCA1 and BRCA2 mutations with survival, chemotherapy sensitivity, and gene mutator phenotype in patients with ovarian cancer. JAMA. 2011 Oct 12;306(14):1557-65. doi: 10.1001/jama.2011.1456.

Reference Type RESULT
PMID: 21990299 (View on PubMed)

Other Identifiers

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2016-A01041-50

Identifier Type: REGISTRY

Identifier Source: secondary_id

ICM-BDD2016/04

Identifier Type: -

Identifier Source: org_study_id

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