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 (ORTRAI)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Genetic: molecular analysis

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judith PASSILDAS JAHANMOHAN, PhD; Phone Number: +33 0463663337; Email: judith.passildas@clermont.unicancer.fr

Study Locations

• France
  • PUY DE DOME
    • Clermont-Ferrand, PUY DE DOME, France, 63001
      • Recruiting
      • Centre Jean Perrin
      • Contact: Judith PASSILDAS JAHANMOHAN, PhD; Email: judith.passildas@clermont.unicancer.fr
      • Principal Investigator: HERRMANN Tressie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: long-term responders; molecular analysis on histological blocks	Genetic: molecular analysis; molecular analysis on histological blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular anomalies retained after biological interpretation and allowing the differentiation of refractory patients from long-term responder patients.	Refractory patients are defined as any patient progressing through the first therapeutic line of platinum-based chemotherapy. Long responders are defined as any patient who has not progressed within 5 years of the end of platinum salt treatment.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenotypic criteria differences between refactory patients and long responder patients	Phenotypic criteria will include BMI, personal history and family history	Through study completion, an average of 1 year
Clinical criteria differences between refactory patients and long responder patients	Clinical criteria will include age at diagnosis, FIGO stage, initial PCI score, CCO score	Through study completion, an average of 1 year
Biological criteria difference between refactory patients and long responder patients	Biological criteria include CA-125	Through study completion, an average of 1 year
Histological criteria differences between refactory patient and long responder patients	Histological criteria include histological type, presence of emboli, Ki-67, RO, RP, WT1, PAX8, PD-L1, CD8, p53, HER2	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Tressie HERRMANN, MD, Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ovarian cancer; long responder
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms
• Other Study ID Numbers: 2025-A01107-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No