Overview
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.
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.
Eligibility
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
