Clinical trial · Interventional
Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Fallopian Tube | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Cancer of the Ovary | Malignant Ovarian Neoplasm | ALIAS | 0.90 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Quality of Life and level of anxiety/depression | Other | — | UNRESOLVED |
| Constitution of a biological collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clinical and Biological Collection
- interventionNames
- Other: Constitution of a biological collection
- Other: Assessment of Quality of Life and level of anxiety/depression
Primary outcomes (1)
- 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 pre-registration
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available