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NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin

Clermont-Ferrand, PUY DE DOME, 63001, France

Location status: Recruiting

Location contact

HERRMANN Tressie, MD

PRINCIPAL_INVESTIGATOR

Judith PASSILDAS JAHANMOHAN, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Molecular Analysis

Genetic

molecular analysis on histological blocks

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Phenotypic criteria differences between refactory patients and long responder patients

    Time frame: Through study completion, an average of 1 year

    Phenotypic criteria will include BMI, personal history and family history

  2. Clinical criteria differences between refactory patients and long responder patients

    Time frame: Through study completion, an average of 1 year

    Clinical criteria will include age at diagnosis, FIGO stage, initial PCI score, CCO score

  3. Biological criteria difference between refactory patients and long responder patients

    Time frame: Through study completion, an average of 1 year

    Biological criteria include CA-125

  4. Histological criteria differences between refactory patient and long responder patients

    Time frame: Through study completion, an average of 1 year

    Histological criteria include histological type, presence of emboli, Ki-67, RO, RP, WT1, PAX8, PD-L1, CD8, p53, HER2

Study contacts

Contact information is provided by the study sponsor or research team.

Judith PASSILDAS JAHANMOHAN, PhD

CONTACT

[email protected]

0463663337 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study 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.

Acronym: ORTRAI

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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