Predicting Disease Progression and/or Recurrence in Cancer
- Conditions
- Patient Reported Outcome MeasuresPancreatic CancerMetastatic CancerSurvival AnalysisColorectal CancerBiliary Tract CancerEsophageal CancerDisease Progression
- Interventions
- Behavioral: Observational Cohort
- Registration Number
- NCT04776837
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- Exclusion Criteria
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Main Cohort Observational 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.
- Primary Outcome Measures
Name Time Method Treatment Response at 1st Scan 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.
- Secondary Outcome Measures
Name Time Method Progression Free Survival - KMC 1 year Estimate distributions of progression free survival using the Kaplan-Meier method.
Progression Free Survival - HR 1 year Use Cox proportional hazards models to obtain hazard ratios for Progression Free Survival for change in tumor markers, ctDNA and PROs.
ROC Curves 1 year 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.
PROs and Biomarkers as predictor of survival using cox proportional hazards model 6 months 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).
Association between baseline PROs, biomarkers and tumor response 6 months The investigators will look at correlations between baseline ctDNA levels, baseline tumor markers and baseline PRO assessments and tumor response.
Treatment Response at 1st Scan - Continuous Outcome 6 months 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).
Overall Survival - KMC 1 year Estimate distributions of overall survival using the Kaplan-Meier method.
Overall Survival - HR 1 year Use Cox proportional hazards models to obtain hazard ratios for Overall Survival for change in tumor markers, ctDNA and PROs.
Associations between baseline PROs, biomarkers, and 6-month survival outcomes 6 months The investigators will look at correlations between baseline ctDNA levels, baseline tumor markers and baseline PRO assessments and 6-month survival outcomes (PFS, OS)
Sarcopenia Analysis 1 year As an exploratory outcome the investigators will compare differences in demographic and clinical characteristics, PROs, and clinical outcomes, between patients with and without sarcopenia.
Skeletal Muscle Analyses 1 year 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.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States