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NCT Number: NCT04776837

Predicting Disease Progression and/or Recurrence in Cancer

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.

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Key information

Conditions

Patient Reported Outcome Measures Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Survival Analysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Observational Cohort

Behavioral

Patients will be followed by collecting clinical data, biospecimens, and quality of life assessment

Primary outcomes

  1. Treatment Response at 1st Scan

    Time frame: 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 outcomes

  1. Treatment Response at 1st Scan - Continuous Outcome

    Time frame: 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).

  2. Progression Free Survival - KMC

    Time frame: 1 year

    Estimate distributions of progression free survival using the Kaplan-Meier method.

  3. Progression Free Survival - HR

    Time frame: 1 year

    Use Cox proportional hazards models to obtain hazard ratios for Progression Free Survival for change in tumor markers, ctDNA and PROs.

  4. Overall Survival - KMC

    Time frame: 1 year

    Estimate distributions of overall survival using the Kaplan-Meier method.

  5. Overall Survival - HR

    Time frame: 1 year

    Use Cox proportional hazards models to obtain hazard ratios for Overall Survival for change in tumor markers, ctDNA and PROs.

  6. ROC Curves

    Time frame: 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.

  7. PROs and Biomarkers as predictor of survival using cox proportional hazards model

    Time frame: 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).

  8. Association between baseline PROs, biomarkers and tumor response

    Time frame: 6 months

    The investigators will look at correlations between baseline ctDNA levels, baseline tumor markers and baseline PRO assessments and tumor response.

  9. Associations between baseline PROs, biomarkers, and 6-month survival outcomes

    Time frame: 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)

  10. Sarcopenia Analysis

    Time frame: 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.

  11. Skeletal Muscle Analyses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 2, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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