Clinical trial NCT04776837: Predicting Disease Progression and/or Recurrence in Cancer
Official title: Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Reported Outcome Measures
Colorectal Cancer
Pancreatic Cancer
Biliary Tract Cancer
Esophageal Cancer
Metastatic Cancer
Disease Progression
Survival Analysis
Keywords: Patient Reported Outcome Measures
Colorectal Cancer
Pancreatic Cancer
Biliary Tract Cancer
Esophageal Cancer
Metastatic Cancer
Disease Progression
Survival Analysis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Primary outcomes:
measure: Treatment Response at 1st Scan
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Response at 1st Scan - Continuous Outcome
timeFrame: 6 months
measure: Progression Free Survival - KMC
timeFrame: 1 year
measure: Progression Free Survival - HR
timeFrame: 1 year
measure: Overall Survival - KMC
timeFrame: 1 year
measure: Overall Survival - HR
timeFrame: 1 year
measure: ROC Curves
timeFrame: 1 year
measure: PROs and Biomarkers as predictor of survival using cox proportional hazards model
timeFrame: 6 months
measure: Association between baseline PROs, biomarkers and tumor response
timeFrame: 6 months
measure: Associations between baseline PROs, biomarkers, and 6-month survival outcomes
timeFrame: 6 months
measure: Sarcopenia Analysis
timeFrame: 1 year
measure: Skeletal Muscle Analyses
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Aparna R Parikh, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: