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Recruiting NCT07361471

Identification of Genetic, Phenotypic, Clinical, Biological and Histological Factors Differentiating Patients With Ovarian Cancer Who Are Refractory to Platinum-based Therapy From Patients Defined as Long-term Responders to Platinum-based Therapy

No phase Interventional Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: molecular analysis.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Identification of Genetic, Phenotypic, Clinical, Biological and Histological Factors Differentiating Patients With Ovarian Cancer Who Are Refractory to Platinum-based Therapy From Patients Defined as Long-term Responders to Platinum-based Therapy.

Overview

After having constituted the ORTRAI cohort using the CONSORE database at the Jean PERRIN Center, the objective is to characterize the patients both clinically and biologically, histologically and genomically. The clinical and biological characterizations will allow us to confirm that our cohort is comparable with data from the literature. The complement of immunohistochemical and molecular analyses will provide more details on the differences between long-term patients responding to treatment and refractory patients.

Interventions

  • Genetic molecular analysis
    molecular analysis on histological blocks

Primary outcome measures

  • Molecular anomalies retained after biological interpretation and allowing the differentiation of refractory patients from long-term responder patients. [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (4)
  • Phenotypic criteria differences between refactory patients and long responder patients [Time frame: Through study completion, an average of 1 year]
  • Clinical criteria differences between refactory patients and long responder patients [Time frame: Through study completion, an average of 1 year]
  • Biological criteria difference between refactory patients and long responder patients [Time frame: Through study completion, an average of 1 year]
  • Histological criteria differences between refactory patient and long responder patients [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Major patient, treated at the Jean Perrin Center, suffering from ovarian cancer at any stage and treated with platinum-based chemotherapy in the first line of treatment.
  • Corresponding to one of the two groups below:
  • Refractory group: patients progressing in the first therapeutic line of platinum-based chemotherapy.
  • Group of long-term responders: patients who have not progressed 5 years after the end of first-line platinum salt treatment
  • Affiliation to a social security scheme
  • Patient who signed the genetic consent form

Exclusion criteria

  • Minor patient
  • Pregnant patient
  • Patient under guardianship or conservatorship
  • Patients who object to the collection of their medical/paramedical data
  • Patient for whom the center does not have biological material for genomic analysis (FFPE block)
  • Patient under administrative, judicial decision or AME (State Medical Aid)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre Jean Perrin — Clermont-Ferrand

Identifiers

NCT: NCT07361471 · 2025-A01107-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗