Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Treatment Response at 1st Scan
研究概览
简要总结
This is a prospective study addressing the challenge of predicting disease progression and/or recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy.
详细描述
This research study is evaluating how patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival) in patient populations with colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy Massachusetts General Hospital Cancer Center
- Patient reported outcomes will be collected through a series of self-administered questionnaires and blood draws will be used to obtain bio and tumor marker information.
- Information will also be collected from the participants electronic medical record.
- Tissue may be obtained for next-generation sequencing.
- The study will conclude after participants are no longer receiving anti-cancer therapies.
- It is expected that about 200 people will take part in this research study
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
- •Inclusion Criteria:
- •Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer.
- •Diagnosed with metastatic disease
- •Age > 18 years.
- •Patients must be starting new line of anti-cancer therapy.
- •Patient must be English-speaking.
排除标准
- •Unwilling or unable to participate in the study
- •Non-metastatic disease
- •Not starting new anti-cancer treatment
- •Cognitive issues interfering with ability to participate.
- •Active, unstable, untreated serious mental illness interfering with ability to participate.
- •Patient does not speak English.
研究组 & 干预措施
Main Cohort
-
Patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival)
-
Prior to starting anti-cancer therapy and at subsequent designated visits (every one month)
-
Collections include:
-
Blood sample
-
Questionnaires quality of life, mood, and symptoms
-
Tissue may be obtained for next-generation sequencing.
干预措施: Observational Cohort (Behavioral)
结局指标
主要结局
Treatment Response at 1st Scan
时间窗: 6 months
The primary outcome is treatment response (RECIST 1.1) at first scan (\>1 month post-treatment start). Both response status (PR vs SD or PD \[including death\]) and clinical benefit status (PR or SD vs PD \[including death\]) will be examined. Primary analyses will compare one month change from baseline in tumor markers, MAF of the selected clonal mutation in ctDNA, and PROs (symptoms, mood, and QOL) individually and a composite score in predicting response and clinical benefit (CB) at first scan.
次要结局
- Progression Free Survival - KMC(1 year)
- Progression Free Survival - HR(1 year)
- ROC Curves(1 year)
- PROs and Biomarkers as predictor of survival using cox proportional hazards model(6 months)
- Association between baseline PROs, biomarkers and tumor response(6 months)
- Treatment Response at 1st Scan - Continuous Outcome(6 months)
- Overall Survival - KMC(1 year)
- Overall Survival - HR(1 year)
- Associations between baseline PROs, biomarkers, and 6-month survival outcomes(6 months)
- Sarcopenia Analysis(1 year)
- Skeletal Muscle Analyses(1 year)
研究者
Aparna Parikh
Principal Investigator
Massachusetts General Hospital