Predicting Disease Progression and/or Recurrence in Cancer

Mass General Brigham

Status: Completed

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

Treatments: Behavioral: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT04776837

18-380

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

200 participants in 1 patient group

Main Cohort

Description:

* 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.

Treatment:

Behavioral: Observational Cohort