Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma

NCT ID: NCT06969833

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 371 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2032-06-27

Brief Summary

Cancer of the ovary and/or peritoneum and/or fallopian tube have a very poor prognosis, and require the implementation of collaborative research tools and new innovative therapies. The main objective of this study is to implement prognostic model of overall survival on patients included prospectively as part of the initial treatment of advanced ovarian and/or peritoneum, and/or fallopian tubes carcinoma (this cohort corresponds to the "Turquoise" care pathway of the Oscar Lambret Center) regardless of the treatment carried out,, integrating both patient's and tumor's characteristics. A clinical and biological database is implemented for this purpose.

371 patients will be recruited over a 5-year period at the Oscar Lambret Center.

The active participation of each patient will be 2 years (from the date of inclusion until the end of study participation, defined by the date of the last intervention specific to the research), then the data from standard care and survival data will be collected until the last follow-up of the last patient, 2 years after the last inclusion.

Detailed Description

This study is part of the management of patients with advanced ovarian and/or peritoneal carcinoma, and/or fallopian tubes (initial treatment) at the Oscar Lambret Center. Once consent is obtained, registration of patient on the trial is possible during initial care, from diagnosis to the day of surgery.If the diagnosis of advanced invasive ovarian and/or peritoneal and/or fallopian tube carcinoma is finally rejected, patients will be secondarily withdrawn from the study and excluded from analysis.

However, this project differs from standard care with:

• an additional blood sample collected at inclusion (28ml)
• left-over routine samples collected from inclusion until the end of oncologic treatment (tumor samples, ascites, and)
• questionnaires about quality of life (QLQ-C30, QLQ-OV28) and anxiety (HADS) are completed at inclusion, then after 3 and 6 courses of systemic treatment (at the time of laparoscopy or surgery), then every 3 months, up to 2 years after inclusion.
• clinical data are entered into a trial-specific database ; in addition to overall survival, numerous variables will be studied, notably the clinical and socio-economic characteristics of the patients, their planned and effective treatment, the morbidity of treatments, event-free survival, evolution of the quality of life, etc.
• Translational research works will be implemented later on left-over routine samples.

Conditions

Cancer of the Ovary; Cancer of the Fallopian Tube; Peritoneal Cancer

Study Design

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

Study Groups

Clinical and Biological Collection

Group Type: EXPERIMENTAL

Constitution of a biological collection

Intervention Type: OTHER

• Left-over tissue samples (tumor tissue of different nature) frozen and secured in paraffin, and derived from standard care, are collected at study entrance until the end of oncologic treatment.
• One blood sample of 28mL is collected at time of inclusion

Assessment of Quality of Life and level of anxiety/depression

Intervention Type: OTHER

Questionnaires QLQ-C30, OV-28 and HADS are completed by the patients at inclusion, after 3 and 6 cycles of systemic treatment, and every 3 months up to 2 years after inclusion

Interventions

Constitution of a biological collection

• Left-over tissue samples (tumor tissue of different nature) frozen and secured in paraffin, and derived from standard care, are collected at study entrance until the end of oncologic treatment.
• One blood sample of 28mL is collected at time of inclusion

Intervention Type: OTHER

Assessment of Quality of Life and level of anxiety/depression

Questionnaires QLQ-C30, OV-28 and HADS are completed by the patients at inclusion, after 3 and 6 cycles of systemic treatment, and every 3 months up to 2 years after inclusion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient aged 18 or over
• Informed consent warranted
• Patient affiliated to a social security regimen
• Suspected or confirmed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer (IIB to IV FIGO stages)
• Inclusion during standard care at the Oscar Lambret Centre, from diagnosis to the day of surgery

Exclusion Criteria

• Patient deprived of liberty or under curatorship or guardianship
• Refusal to participate

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

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Oscar Lambret

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alicia Probst, PhD

Role: CONTACT

promotion@o-lambret.fr

33320295918

Lucie BRESSON, MD, PhD

Role: CONTACT

33320295918

Facility Contacts

Lucie BRESSON, MD, PhD

Role: primary

33320295918

Other Identifiers

BCB-OVAIRE-2205

Identifier Type: -

Identifier Source: org_study_id