Ovarian CancerORTRAINCT07361471
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
A study testing molecular analysis in people with Ovarian Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- molecular analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, PUY DE DOME, 63001
Judith PASSILDAS JAHANMOHAN, PhD, judith.passildas@clermont.unicancer.fr
HERRMANN Tressie, MD
About this study
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.
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.
- Conditions
- Ovarian Cancer
- Being tested
- molecular analysis
- Keywords
- ovarian cancer, long responder
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular analysisGenetic
molecular analysis on histological blocks
| Study group | Role | What they receive |
|---|---|---|
| long-term responders | Experimental | molecular analysis on histological blocks Receives: Genetic: molecular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Phenotypic criteria differences between refactory patients and long responder patients
Phenotypic criteria will include BMI, personal history and family history
Measured: 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
Measured: Through study completion, an average of 1 year
Biological criteria difference between refactory patients and long responder patients
Biological criteria include CA-125
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start22 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is a single-centre study with a prospective part (living patients) and a retrospective part (deceased patients) involving data collection via the patient's medical software. A molecular analysis on histological blocks taken at the time of diagnosis will be carried out as part of the study. This analysis may potentially generate new genomic data to classify patients with ovarian cancer. Could result in the incidental discovery of abnormalities, which may eventually modify the management of the patient, notably her monitoring and screening for other pathologies. No additional sampling will be carried out as part of the study.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tressie HERRMANN, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361471
- Sponsor's protocol ID
- 2025-A01107-42
- Acronym
- ORTRAI
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07361471
- Acronym / sponsor ID
- ORTRAI / 2025-A01107-42
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, long responder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a single-centre study with a prospective part (living patients) and a retrospective part (deceased patients) involving data collection via the patient's medical software. A molecular analysis on histological blocks taken at the time of diagnosis will be carried out as part of the study. This analysis may potentially generate new genomic data to classify patients with ovarian cancer. Could result in the incidental discovery of abnormalities, which may eventually modify the management of the patient, notably her monitoring and screening for other pathologies. No additional sampling will be carried out as part of the study.
| Arm | Type | Receives |
|---|---|---|
| long-term responders | Experimental | Genetic: molecular analysismolecular analysis on histological blocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Affiliation to a social security scheme
- Patient who signed the genetic consent form
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular analysismolecular analysis on histological blocks | Genetic | long-term responders |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tressie HERRMANN, MD principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing molecular analysis in people with Ovarian Cancer, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith PASSILDAS JAHANMOHAN, PhD (0463663337 ext. +33, judith.passildas@clermont.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.