Predicting Disease Progression and/or Recurrence in Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776837
• Other study ID #: 18-380
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: November 19, 2021

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Disease Progression
• Esophageal Cancer
• Esophageal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Pancreatic Cancer
• Pancreatic Neoplasms
• Patient Reported Outcome Measures
• Survival Analysis

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Progression Free Survival - KMC	Estimate distributions of progression free survival using the Kaplan-Meier method.	1 year
Secondary	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
Secondary	Overall Survival - KMC	Estimate distributions of overall survival using the Kaplan-Meier method.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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