Clinical trial NCT06969833: Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer of the Ovary
Cancer of the Fallopian Tube
Peritoneal Cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 371
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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invasive ovarian and/or peritoneal and/or fallopian tube carcinoma is finally rejected, patients will be secondarily withdrawn from the study and excluded from analysis.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.

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

Primary outcomes:
measure: 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.
timeFrame: Up to 7 years after the first inclusion
Secondary outcomes:
measure: 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
timeFrame: Up to 7 years after the first inclusion
measure: 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
timeFrame: Up to 7 years after the first inclusion
measure: To describe both initial characteristics of the patients and their disease characteristics
timeFrame: At baseline
measure: To describe the therapeutic management of these patients, as planned initially and finally carried out
timeFrame: Up to 7 years after the first inclusion
measure: To describe the morbidity events of first-line treatments
timeFrame: Up to 7 years after the first inclusion
measure: To describe the distribution of events (recurrence or progression) on patients who have received platinum treatment
timeFrame: Up to 7 years after the first inclusion
measure: To estimate overall survival (OS) and event-free survival (EFS) of patients
timeFrame: Up to 7 years after the first inclusion
measure: To estimate post-relapse overall survival (OS), and post-relapse event-free survival (EFS) of patients
timeFrame: Up to 7 years after the first inclusion
measure: To assess the quality of life of patients according to the score calculated with the health-related quality of life questionnaire (QLQ-C30)
timeFrame: At inclusion, 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 inclusion
measure: 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)
timeFrame: At inclusion, 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 inclusion
measure: To assess the level of anxiety of patients according to the anxiety score calculated with Hospital Anxiety and Depression scale
timeFrame: At inclusion, 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 inclusion
measure: To assess the level of depression of patients according to the depression score calculated with Hospital Anxiety and Depression scale
timeFrame: At inclusion, 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 inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
References: