Predicting Disease Progression and/or Recurrence in Cancer

NCT ID: NCT04776837

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2021-11-19

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

Conditions

Patient Reported Outcome Measures; Colorectal Cancer; Pancreatic Cancer; Biliary Tract Cancer; Esophageal Cancer; Metastatic Cancer; Disease Progression; Survival Analysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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 sample
• Questionnaires quality of life, mood, and symptoms
• Tissue may be obtained for next-generation sequencing.

Observational Cohort

Intervention Type: BEHAVIORAL

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

Interventions

Observational Cohort

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aparna Parikh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aparna R Parikh, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

18-380

Identifier Type: -

Identifier Source: org_study_id