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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Oscar Lambret

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Constitution of a biological collection

    Other intervention

    * 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

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

    Other intervention

    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

Treatment groups

371 Participants
are divided into 1 treatment group
Group A: Clinical and Biological CollectionExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Up to 7 years after the first pre-registration

Secondary outcomes

1

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

* Clinical database created, functional and completed regularly. * Biological collection constitued from additional blood samples (1 blood sample of 28ml per patient at the time of inclusion) and from biological extra-samples of standard care (biopsy, ascites)

Time frame
Up to 7 years after the first pre-registration
2

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

* Event-free survival will be defined as the time from the date of histological diagnosis to the date of progression, relapse or death from any cause. Patients alive and event-free at the time of the last report will be censored at this date. * Post-relapse event-free survival will be defined as the time from the date of the first recurrence to the date of the next event: progression, relapse or death from any cause. Patients who are alive and event-free at the latest will be censored at this date. * The multivariate Cox model will be used to analyze the association of EFS with: 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 ; Tumor genetics: HRD or HRP phenotype, methylation, etc. ; Tumor microenvironment: presence of tumor-infiltrating lymphocytes, etc.

Time frame
Up to 7 years after the first pre-registration
3

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

Clinical data of patients and disease characteristics will be described using traditional methods of descriptive statistics. The clinical data include: age, weight, BSA, OMS score, ASA score (Physical Status Classification System), French deprivation index, medical history and comorbidities Disease characteristics include: FIGO stage, ascite, result of biological dosages (CA-125, CA-19.9, inhibine, ACE: carcinoma embryonic antigen), histology, carcinosis index Categorical variables will be presented as frequency and percentage Continuous variables will be presented as median with their extremes or interquartiles, and as mean with standard deviation (the list of data can't be detailed exhaustively in CT.gov).

Time frame
At baseline
4

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

The data obtained from standard care will described with usual descriptive statistics: * Rate of surgery, complete or not * Delay/timing of surgery * Rate of systemic treatment: type of chemotherapy and number of courses This multiple measures will be aggregated to mesure the rate of patients receiving the treatment as planned initially, and the rate of patients receiving a treatment different as planned initially.

Time frame
Up to 7 years after the first pre-registration

Other outcomes

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