LCCC 1938: Investigating the Relationship Between Circulating Tumor Cell Cultures Treatment Response and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Correlation between treatment response in CTCs and in vivo
研究概览
简要总结
The purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.
详细描述
This study will isolate circulating tumor cells (CTCs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. The CTCs will be cultured and given the same treatment as the patient received. The main goals of this project are 1) to assess CTC cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a metastatic solid tumor malignancy with either liver and/or lung metastasis. Patients with newly diagnosed metastatic disease who have not had systemic therapy or are progressing on systemic therapy fitting one of the following cohorts:
- •Patients had a tumor or liquid biopsy with molecular analysis (genomic analysis or other type of molecular characterization) resulting in a therapeutic target with planned targeted therapy by the patient's treating physician.
- •Gastric cancer patients who have failed the first and second line chemotherapy.
- •Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment.
- •Scheduled to initiate systemic treatment for management of their disease. The systemic treatment will be either cytotoxic chemotherapy or targeted therapy but not checkpoint inhibitor immunotherapy.
- •≥18 years of age
- •Written informed consent obtained and signed
- •Able to have blood collection without excessive difficulty
排除标准
- •Patient unwilling or unable to complete informed consent
- •Currently pregnant or lactating women
- •Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
结局指标
主要结局
Correlation between treatment response in CTCs and in vivo
时间窗: Initiation of trial to 24 months post-initiation
To estimate the agreement between CTC cultures' response to treatment, dichotomized as either yes or no response, to the clinical response in patients to treatment, dichotomized as either progressive disease (PD) versus complete response (CR), partial response (PR), or stable disease (SD)
次要结局
- Sensitivity, specificity, and predictive values of CTC cultures' treatment response(Initiation of trial to 24 months post-initiation)