Predicting Disease Progression and/or Recurrence in Cancer

Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers

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.

Study Overview

• Status: Completed
• Conditions: Disease Progression; Colorectal Cancer; Pancreatic Cancer; Esophageal Cancer; Metastatic Cancer; Biliary Tract Cancer; Patient Reported Outcome Measures; Survival Analysis
• Intervention / Treatment: Behavioral: Observational Cohort

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

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer and receiving anti cancer treatment at Massachusetts General Hospital Cancer Center

Description

• 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.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 sampleQuestionnaires quality of life, mood, and symptomsTissue may be obtained for next-generation sequencing.

Behavioral: Observational Cohort; Patients will be followed by collecting clinical data, biospecimens, and quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months
Progression Free Survival - KMC	Estimate distributions of progression free survival using the Kaplan-Meier method.	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.	1 year
Overall Survival - KMC	Estimate distributions of overall survival using the Kaplan-Meier method.	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.	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.	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).	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.	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)	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Aparna R Parikh, MD, MS, Massachusetts General Hospital

Publications and helpful links

General Publications

• Jarnagin JX, Saraf A, Baiev I, Chi G, van Seventer EE, Mojtahed A, Allen JN, Clark JW, Blaszkowsky L, Giantonio BJ, Weekes CD, Klempner SJ, Franses JW, Roeland EJ, Goyal L, Siravegna G, Horick N, Corcoran RB, Nipp RD, Parikh AR. Patient-Reported Outcomes, Tumor Markers, and Survival Outcomes in Advanced GI Cancer. JAMA Netw Open. 2023 Nov 1;6(11):e2343512. doi: 10.1001/jamanetworkopen.2023.43512.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Disease Progression; Colorectal Cancer; Metastatic Cancer; Esophageal Cancer; Biliary Tract Cancer; Patient Reported Outcome Measures; Survival Analysis
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Pancreatic Diseases; Biliary Tract Diseases; Colonic Diseases; Neoplastic Processes; Esophageal Diseases; Pathological Conditions, Signs and Symptoms; Biliary Tract Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Disease Progression; Neoplasm Metastasis; Pancreatic Neoplasms
• Other Study ID Numbers: 18-380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor- Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No