Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging

NCT ID: NCT06084195

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2029-10-31

Brief Summary

The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance

Detailed Description

After being informed about the study and potential risks, all patient giving wirtting informed consent.

During surgery, tissue and blood samples will be conserved for the study. In this study will be compared images obtained in vivo before surgical management, ex vivo images obtained on excised tissues during surgery, histological data obtained during surgery.

Conditions

High Grade Serous Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single arm

single arm

Group Type: EXPERIMENTAL

Blood sample and tissue sample

Intervention Type: BIOLOGICAL

During the surgery :

• Tissus sample : primary tumor and metastasis
• blood sample : 3 EDTA tubes
• ex vivo MRI data

Interventions

Blood sample and tissue sample

During the surgery :

• Tissus sample : primary tumor and metastasis
• blood sample : 3 EDTA tubes
• ex vivo MRI data

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patient aged >18
• Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment
• Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,
• Patient who has given informed, written and express consent,
• Patient affiliated with a French health insurance scheme.

Exclusion Criteria

• Early-stage disease (FIGO <IIIB) or presence of extraperitoneal metastases,
• Patient who will not have surgery
• Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
• Patient under guardianship, curatorship or safeguarding of justice,
• Pregnant and/or nursing patient,
• Patient with a history of other cancers within 5 years/10 years prior to inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NOUGARET Stephanie, MD

Role: STUDY_DIRECTOR

INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

Locations

NOUGARET Stephanie

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

MOUSSION Aurore

Role: CONTACT

aurore.moussion@icm.unicancer.fr

0467613102 ext. +33

Texier Emmanuelle

Role: CONTACT

emmanuelle.texier@icm.unicancer.fr

0467613102 ext. +33

Facility Contacts

NOUGARET Stephanie, MD

Role: primary

stephanie.nougaret@icm.unicancer.fr

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Other Identifiers

PROICM 2023-02 MRO

Identifier Type: -

Identifier Source: org_study_id