Deciphering Mechanisms Underlying Cancer Immunogenicity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 3
- 主要终点
- Percentage of CD4 and CD8 T cells expressing PD-1
研究概览
简要总结
This trial is a translational, open-label, multicentric, prospective cohort study of 1100 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.
The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.
Patients with any of the following tumor types may be enrolled in the trial:
- Head and neck cancer,
- Ovarian cancer,
- Cervical cancer,
- Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
- Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)
Each tumor type will be considered as an independent cohort.
For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.
Study participation of each patient will be 5 years.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)
- •Age ≥ 18 years at the time of study entry
- •Patient followed within a standard of care procedure or clinical trial
- •ECOG Performance status 0-2
- •Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- •Patient affiliated to a Social Health Insurance in France
- •Patient may participate to other clinical trials
排除标准
- •Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
- •Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)
- •Patient pregnant, or breast-feeding
- •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship
研究组 & 干预措施
Patient with local and/or metastatic solid malignant tumor
Patient receiving an anticancer treatment in the context of their standard care.
干预措施: Blood samples, tumor biopsy specimens and ascites samples will be collected. (Other)
结局指标
主要结局
Percentage of CD4 and CD8 T cells expressing PD-1
时间窗: 5 years for each patient
次要结局
- Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples(5 years for each patient)