Predicting Disease Progression and/or Recurrence in Cancer
Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2021
CompletedAugust 4, 2022
August 1, 2022
2.5 years
January 30, 2020
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Treatment Response at 1st Scan - Continuous Outcome
6 months
Progression Free Survival - KMC
1 year
Progression Free Survival - HR
1 year
Overall Survival - KMC
1 year
Overall Survival - HR
1 year
- +6 more secondary outcomes
Study Arms (1)
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.
Interventions
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessment
Eligibility Criteria
Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer and receiving anti cancer treatment at Massachusetts General Hospital Cancer Center
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Biospecimen
Blood samples will be collected serially throughout study treatment. It will be processed to separate blood cell pellet from plasma and each component will be aliquoted and frozen for subsequent analyses. Tissue will be obtained for next-generation sequencing from formalin fixed archival tumor.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aparna R Parikh, MD, MS
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 30, 2020
First Posted
March 2, 2021
Study Start
May 15, 2019
Primary Completion
November 19, 2021
Study Completion
November 19, 2021
Last Updated
August 4, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication.
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor- Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research