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

Study of Prognostic Factors Associated With Overall Survival in Patients Initially Treated for Advanced Ovarian and/or Peritoneum and/or Fallopian Tubes Carcinoma: Analysis Using a Prospective Clinico-Biological Database

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 pre-registration 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 pre-registration.

Study Overview

• Status: Recruiting
• Conditions: Cancer of the Ovary; Peritoneal Cancer; Cancer of the Fallopian Tube
• Intervention / Treatment: Other: Constitution of a biological collection; Other: Assessment of Quality of Life and level of anxiety/depression

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, pre-registration of patient on the trial is possible during initial care, from diagnosis and before the confirmation of FIGO stage; a trial number is assigned to the patient.

If the diagnosis of advanced invasive ovarian and/or peritoneal and/or fallopian tube carcinoma is confirmed (FIGO stage IIB to IV), the patient is included. On the contrary (FIGO stage IA to IIA, or other disease), patient is not included on the trial and excluded from analysis.

Pre-registration and inclusion are possible the same day if the definitive FIGO stage is confirmed.

However, this project differs from standard care with:

• an additional blood sample, collected once inclusion is confirmed (28ml)
• left-over routine samples collected from pre-registration until two years after pre-registration (tumor samples, ascites, zetc.)
• questionnaires about quality of life (QLQ-C30, QLQ-OV28) and anxiety (HADS) are completed after pre-registration, 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 pre-registration. Patients can choose printed and/or digital questionnaires.
• 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.

• Study Type: Interventional
• Enrollment (Estimated): 371
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia Probst, PhD; Phone Number: 33320295918; Email: promotion@o-lambret.fr
• Study Contact Backup: Name: Lucie BRESSON, MD, PhD; Phone Number: 33320295918

Study Locations

• France
  • Lille, France
    • Recruiting
    • Centre Oscar Lambret
    • Contact: Lucie BRESSON, MD, PhD; Phone Number: 33320295918

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility criteria for pre-registration:

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

Non eligibility criteria for pre-registration:

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

Inclusion criteria:

• Confirmed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer (IIB to IV FIGO stages)

Exclusion criteria:

• Dismissed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer , or other type of cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Clinical and Biological Collection

Other: 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 once inclusion is confirmed; Other: Assessment of Quality of Life and level of anxiety/depression; Questionnaires QLQ-C30, OV-28 and HADS are completed by the patients after pre-registration, then after 3 and 6 cycles of systemic treatment, and every 3 months up to 2 years after pre-registration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify prognostic factors associated with overall survival on patients included prospectively as part of the initial treatment integrating both patient's and tumor's characteristics, using a multivariate Cox model.	Overall survival (OS) will defined as the time from the date of histological diagnosis to the date of death whatever the cause. Post-relapse OS will be defined as the time from the date of first recurrence to the date of death from any cause. The multivariate Cox model will be used to analyze the association of overall survival with prognostic factors: Patient's characteristics: age, weight, body-surface area, Performance status score, ASA score (Physical Status Classification System), antecedents and comorbidities; FIGO stage at diagnosis; Histological characteristics and histological subtype of tumor: high-grade serous, low-grade serous, endometrioid, clear-cell, mucinous, undifferentiated carcinoma; Tumor genetics: HRD or HRP phenotype, methylation, etc.; Tumor microenvironment: presence of tumor-infiltrating lymphocytes, presence of tumor-associated Macrophages, and expression of programmed cell death protein-1	Up to 7 years after the first pre-registration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe both initial characteristics of the patients and their disease characteristics	Clinical data of patients and disease characteristics will be described using traditional methods of descriptive statistics. The clinical data include: age, weight, BSA, OMS score, ASA score (Physical Status Classification System), French deprivation index, medical history and comorbidities Disease characteristics include: FIGO stage, ascite, result of biological dosages (CA-125, CA-19.9, inhibine, ACE: carcinoma embryonic antigen), histology, carcinosis index Categorical variables will be presented as frequency and percentage Continuous variables will be presented as median with their extremes or interquartiles, and as mean with standard deviation (the list of data can't be detailed exhaustively in CT.gov).	At baseline
To develop a prospective clinico-biological database of patients with advanced ovarian and/or peritoneal and/or fallopian tube carcinoma included during first-line treatment	Clinical database created, functional and completed regularly.; Biological collection constitued from additional blood samples (1 blood sample of 28ml per patient at the time of inclusion) and from biological extra-samples of standard care (biopsy, ascites)	Up to 7 years after the first pre-registration
To develop and validate prognostic models of event-free survival (EFS) on patients included prospectively as part of the initial treatment, integrating both patient's and tumor's characteristics, using a multivariate Cox model	Event-free survival will be defined as the time from the date of histological diagnosis to the date of progression, relapse or death from any cause. Patients alive and event-free at the time of the last report will be censored at this date.; Post-relapse event-free survival will be defined as the time from the date of the first recurrence to the date of the next event: progression, relapse or death from any cause. Patients who are alive and event-free at the latest will be censored at this date.; The multivariate Cox model will be used to analyze the association of EFS with: Patient's characteristics: age, weight, body-surface area, Performance status score, ASA score (Physical Status Classification System), antecedents and comorbidities ; FIGO stage at diagnosis ; Histological characteristics and histological subtype of tumor ; Tumor genetics: HRD or HRP phenotype, methylation, etc. ; Tumor microenvironment: presence of tumor-infiltrating lymphocytes, etc.	Up to 7 years after the first pre-registration
To describe the therapeutic management of these patients, as planned initially and finally carried out	The data obtained from standard care will described with usual descriptive statistics: Rate of surgery, complete or not; Delay/timing of surgery; Rate of systemic treatment: type of chemotherapy and number of courses This multiple measures will be aggregated to mesure the rate of patients receiving the treatment as planned initially, and the rate of patients receiving a treatment different as planned initially.	Up to 7 years after the first pre-registration
To describe the morbidity events of first-line treatments	The number of events will be described by type and by grade (according to NCI-CTCAE V6.0 scale), and for the different phases of treatment (neoadjuvant chemotherapy, surgery, adjuvant chemotherapy).	Up to 7 years after the first pre-registration
To describe the distribution of events (recurrence or progression) on patients who have received platinum treatment	These events will be described according to their time of occurrence in relation to the platinum treatment: during platinum treatment, less than 6 months after the end of platinum treatment, between 6 and 12 months after the end of platinum treatment, after 12 months of platinum treatment	Up to 7 years after the first pre-registration
To estimate overall survival (OS) and event-free survival (EFS) of patients	Refer to primary outcome for definition and estimation of OS.; Refer to secondary outcome linked to prognostic models for definition and estimation of EFS.	Up to 7 years after the first pre-registration
To estimate post-relapse overall survival (OS), and post-relapse event-free survival (EFS) of patients	Refer to primary outcome for definition and estimation of OS.; Refer to secondary outcome linked to prognostic models for definition and estimation of EFS.	Up to 7 years after the first pre-registration
To assess the quality of life of patients according to the score calculated with the health-related quality of life questionnaire (QLQ-C30)		After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the quality of life of patients according to the score calculated with the ovarian cancer module of the health-related quality of life questionnaire (QLQ-OV28)		After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the level of anxiety of patients according to the anxiety score calculated with Hospital Anxiety and Depression scale		After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the level of depression of patients according to the depression score calculated with Hospital Anxiety and Depression scale		After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): June 27, 2032
• Study Completion (Estimated): June 27, 2032

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: May 9, 2025
• First Posted (Actual): May 14, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• 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; Fallopian Tube Diseases; Ovarian Neoplasms; Fallopian Tube Neoplasms
• Other Study ID Numbers: BCB-OVAIRE-2205; 2023-A02449-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No