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.
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
Study Type
OBSERVATIONAL
Enrollment
200
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessment
Massachusetts General Hospital
Boston, Massachusetts, United States
Treatment Response at 1st Scan
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.
Time frame: 6 months
Treatment Response at 1st Scan - Continuous Outcome
Change from baseline to one month for each variable (tumor markers \[CEA, CA19-9\], ctDNA, and PROs \[symptoms, mood, QOL\]) will be evaluated individually as a predictor of percent change in tumor measurements at first scan (RECIST 1.1).
Time frame: 6 months
Progression Free Survival - KMC
Estimate distributions of progression free survival using the Kaplan-Meier method.
Time frame: 1 year
Progression Free Survival - HR
Use Cox proportional hazards models to obtain hazard ratios for Progression Free Survival for change in tumor markers, ctDNA and PROs.
Time frame: 1 year
Overall Survival - KMC
Estimate distributions of overall survival using the Kaplan-Meier method.
Time frame: 1 year
Overall Survival - HR
Use Cox proportional hazards models to obtain hazard ratios for Overall Survival for change in tumor markers, ctDNA and PROs.
Time frame: 1 year
ROC Curves
The investigators will compare the predictive ability of change in tumor markers, ctDNA, and PROs in these models using time-dependent ROC curves evaluated at specific timepoints including 6 and 12 months.
Time frame: 1 year
PROs and Biomarkers as predictor of survival using cox proportional hazards model
The investigators will run multivariable Cox proportional hazards regression with purposeful selection of covariates to explore combinations of variables (change in tumor markers \[CEA, CA19-9\], ctDNA, and PROs \[symptoms, mood, QOL\]) as predictors of survival (PFS and OS).
Time frame: 6 months
Association between baseline PROs, biomarkers and tumor response
The investigators will look at correlations between baseline ctDNA levels, baseline tumor markers and baseline PRO assessments and tumor response.
Time frame: 6 months
Associations between baseline PROs, biomarkers, and 6-month survival outcomes
The investigators will look at correlations between baseline ctDNA levels, baseline tumor markers and baseline PRO assessments and 6-month survival outcomes (PFS, OS)
Time frame: 6 months
Sarcopenia Analysis
As an exploratory outcome the investigators will compare differences in demographic and clinical characteristics, PROs, and clinical outcomes, between patients with and without sarcopenia.
Time frame: 1 year
Skeletal Muscle Analyses
As an exploratory outcome the investigators will compare differences in demographic and clinical characteristics, PROs, and clinical outcomes, between patients by skeletal muscle index and density.
Time frame: 1 year
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