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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Dismissed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer , or other type of cancer
研究组 & 干预措施
Clinical and Biological Collection
干预措施: Constitution of a biological collection (Other)
Clinical and Biological Collection
干预措施: Assessment of Quality of Life and level of anxiety/depression (Other)
结局指标
主要结局
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.
时间窗: Up to 7 years after the first pre-registration
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
次要结局
- To describe both initial characteristics of the patients and their disease characteristics(At baseline)
- 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)(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 develop a prospective clinico-biological database of patients with advanced ovarian and/or peritoneal and/or fallopian tube carcinoma included during first-line treatment(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(Up to 7 years after the first pre-registration)
- To describe the therapeutic management of these patients, as planned initially and finally carried out(Up to 7 years after the first pre-registration)
- To describe the morbidity events of first-line treatments(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(Up to 7 years after the first pre-registration)
- To estimate overall survival (OS) and event-free survival (EFS) of patients(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(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)(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(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(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)