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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Jean Perrin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

Minor patient

Pregnant patient

Patient under guardianship or conservatorship

Patients who object to the collection of their medical/paramedical data

Trial design

Design model

Single group

Treatments tested in this trial

  • molecular analysis

    Genetic

    molecular analysis on histological blocks

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: long-term respondersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Phenotypic criteria differences between refactory patients and long responder patients

Phenotypic criteria will include BMI, personal history and family history

Time frame
Through study completion, an average of 1 year
2

Clinical criteria differences between refactory patients and long responder patients

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

Time frame
Through study completion, an average of 1 year
3

Biological criteria difference between refactory patients and long responder patients

Biological criteria include CA-125

Time frame
Through study completion, an average of 1 year
4

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

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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