Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Cohort |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Cohort | Behavioral | Patients will be followed by collecting clinical data, biospecimens, and quality of life assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Progression Free Survival - KMC |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer and receiving anti cancer treatment at Massachusetts General Hospital Cancer Center
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aparna R Parikh, MD, MS | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37976066 | Result | Jarnagin JX, Saraf A, Baiev I, Chi G, van Seventer EE, Mojtahed A, Allen JN, Clark JW, Blaszkowsky L, Giantonio BJ, Weekes CD, Klempner SJ, Franses JW, Roeland EJ, Goyal L, Siravegna G, Horick N, Corcoran RB, Nipp RD, Parikh AR. Patient-Reported Outcomes, Tumor Markers, and Survival Outcomes in Advanced GI Cancer. JAMA Netw Open. 2023 Nov 1;6(11):e2343512. doi: 10.1001/jamanetworkopen.2023.43512. |
Not provided
Not provided
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
Data can be shared no earlier than 1 year following the date of publication.
Contact the Partners Innovations team at http://www.partners.org/innovation
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2020 | Jan 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2020 | Jan 4, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004938 | Esophageal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Estimate distributions of progression free survival using the Kaplan-Meier method. |
| 1 year |
| 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 |
| Overall Survival - KMC | Estimate distributions of overall survival using the Kaplan-Meier method. | 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |