Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Constitution of a biological collection, Assessment of Quality of Life and level of anxiety/depression.
- Who it may be relevant to
- Registry conditions: Cancer of the Ovary, Cancer of the Fallopian Tube, Peritoneal Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
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.
Interventions
- 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
Primary outcome measures
- 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. [Time frame: Up to 7 years after the first pre-registration]
Secondary outcome measures (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 [Time frame: 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 [Time frame: Up to 7 years after the first pre-registration]
- To describe both initial characteristics of the patients and their disease characteristics [Time frame: At baseline]
- To describe the therapeutic management of these patients, as planned initially and finally carried out [Time frame: Up to 7 years after the first pre-registration]
- To describe the morbidity events of first-line treatments [Time frame: 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 [Time frame: Up to 7 years after the first pre-registration]
- To estimate overall survival (OS) and event-free survival (EFS) of patients [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Oscar Lambret — Lille
Identifiers
NCT: NCT06969833 · BCB-OVAIRE-2205 · 2023-A02449-36