Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2026-01-01 @ 2:16 AM
Study NCT ID:
NCT06969833
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma
Sponsor:
Centre Oscar Lambret
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCB-OVAIRE
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: