Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019.

NCT04573933 | Completed

• 1 other identifier: BREIZH-PARPi (29BRC20.0092)
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers, 5th for mortality, and its origin is still imperfectly known. It has a silent history for a long time, is often diagnosed late, and the prognosis is poor with a high relapse rate. It is therefore necessary to assess and prevent the risk of relapse, in order to establish a diagnosis as early as possible, and thus set up the appropriate treatment. Poly-ADP-Ribose Polymerase (PARP) inhibitors such as OLAPARIB and NIRAPARIB are effective in maintenance to prevent the risk of relapse in patients with recurrent platinum-sensitive ovarian cancer, as proved by recent data from the medical literature. Nevertheless, there may be a difference between "real life" and clinical trial data. Thus, the objective of this cohort is to assess whether the efficacy and safety of PARP inhibitors is the same in Finistère patients as in the scientific literature.

Conditions

Ovarian Neoplasm

Keywords

recurrent platinum-sensitive ovarian cancer ;; PARP inhibitors ;; Efficacy ;; Safety ;; Finisterian data

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Time from date of start of parp inhibitor therapy to date of first documented progression

  Through study completion, assessed up to 80 months

Secondary Outcomes (2)

• - Overall survival

  Through study completion, assessed up to 80 months

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who started treatment with PARP inhibitors on maintenance, between January 1, 2014 and December 31, 2019, for recurrent platinum-sensitive ovarian cancer

You may qualify if:

• ≥ 18 years old
• High grade serous or clear cell ovarian cancer or endometrioid, including primary peritoneal cancer and fallopian tubes
• Treatment with PARP inhibitor (OLAPARIB, NIRAPARIB) in maintenance after sensitive platinum relapse
• No objection made

You may not qualify if:

• \- Patients under judicial protection (guardianship)
• Refusal to participate

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (4)

Clinique Pasteur

Brest, 29200, France

Location

Clinique Pasteur

Brest, 29229, France

Location

CH des pays de Morlaix

Morlaix, 29672, France

Location

CHIC

Quimper, 29000, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 5, 2020
• Study Start: June 29, 2020
• Primary Completion: July 29, 2020
• Study Completion: August 29, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 8 months and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (4)