NCT03862677招募中不适用
Determining Prognostic Immune Markers in Patients With Ovarian Cancer
Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年8月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS
研究概览
简要总结
The IMPRoVE study is a prospective, non-interventional, explorative cohort study to determine prognostic immune markers in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (EOC).
详细描述
Tumor material, ascites (if possible) and blood samples for immune monitoring will be collected from patients with primary and recurrent EOC undergoing surgery, chemotherapy and/or immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with (suspicion of) primary or recurrent EOC with an indication for surgery, chemotherapy and/or immunotherapy.
- •Age ≥18 years.
- •WHO performance status 0-
- •Accessible for treatment and follow-up.
- •Written informed consent.
排除标准
- •Other active malignancy in past 5 years prior to entry into the study, except for treated non-melanoma skin cancer.
- •Any known severe infection like HIV, hepatitis A, B and C.
- •Receiving immune suppressive treatment.
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
研究组 & 干预措施
Patients with (suspicion of) primary EOC
干预措施: No intervention (Other)
Patients with recurrent EOC
干预措施: No intervention (Other)
结局指标
主要结局
Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS
时间窗: 5 years
次要结局
- Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS(5 years)
- Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS(5 years)
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS(5 years)
- Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS(5 years)
- Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with recurrent EOC before and during treatment and the association with OS(5 years)
- Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with primary EOC before and during treatment and the association with PFS(5 years)
- Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS(5 years)
- Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS(5 years)
- Influence of the mMDSC/DC ratio and separate immune cell populations on the tumor specific and general immune response (assessed by mixed lymphocyte reaction, functional suppression assay and lymphocyte stimulation test)(5 years)
- Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with primary EOC for the different chemotherapeutic and immunotherapeutic treatment modalities(5 years)
- Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with recurrent EOC for the different chemotherapeutic and immunotherapeutic treatment modalities(5 years)
- Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with PFS(5 years)
- Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with PFS(5 years)
- Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS(5 years)
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS(5 years)
- Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS(5 years)
- Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with primary EOC before and during treatment and the association with OS(5 years)
- Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS(5 years)
- Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS(5 years)
- Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS(5 years)
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS(5 years)
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS(5 years)
- Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS(5 years)
- Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS(5 years)
- Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS(5 years)
- Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS(5 years)
- Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with OS(5 years)
- Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with OS(5 years)
研究者
J.R. Kroep
Principal Investigator MD PhD
Leiden University Medical Center
研究点 (1)
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