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

NCT06969833 | Recruiting

• 2 other identifiers: BCB-OVAIRE-22052023-A02449-36
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

  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

  Up to 7 years after the first pre-registration

• To describe both initial characteristics of the patients and their disease characteristics

  At baseline

• To describe the therapeutic management of these patients, as planned initially and finally carried out

  Up to 7 years after the first pre-registration

• To describe the morbidity events of first-line treatments

  Up to 7 years after the first pre-registration

Study Arms (1)

Clinical and Biological Collection

EXPERIMENTAL

Other: Constitution of a biological collection; Other: Assessment of Quality of Life and level of anxiety/depression

Interventions

Assessment of Quality of Life and level of anxiety/depression OTHER

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

Clinical and Biological Collection

Constitution of a biological collection 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 once inclusion is confirmed

Clinical and Biological Collection

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, France

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Central Study Contacts

Alicia Probst, PhD

CONTACT

33320295918; promotion@o-lambret.fr

Lucie BRESSON, MD, PhD

CONTACT

33320295918

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: May 14, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): June 27, 2032
• Study Completion (Estimated): June 27, 2032
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)