- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (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
Study Type
Enrollment (Estimated)
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
-
-
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
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: long-term responders
molecular analysis on histological blocks
|
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.
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. |
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
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Through study completion, an average of 1 year
|
Biological criteria include CA-125
|
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
|
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
Investigators
- Principal Investigator: Tressie HERRMANN, MD, Centre Jean PERRIN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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