Patient Reported Outcome MeasuresNCT04776837
Predicting Disease Progression and/or Recurrence in Cancer
An observational study of Patient Reported Outcome Measures and Colorectal Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Reported Outcome Measures, Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- Observational Cohort
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 19 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer and receiving anti cancer treatment at Massachusetts General Hospital Cancer Center
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers
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.
Read the 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
- Being tested
- Observational Cohort
- Keywords
- Patient Reported Outcome Measures, Colorectal Cancer, Pancreatic Cancer, Biliary Tract Cancer, Esophageal Cancer, Metastatic Cancer, Disease Progression, Survival Analysis
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms, Esophageal Neoplasms, Neoplasm Metastasis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational CohortBehavioural
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
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).
Measured: 6 months
Progression Free Survival - KMC
Estimate distributions of progression free survival using the Kaplan-Meier method.
Measured: 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.
Measured: 1 year
Overall Survival - KMC
Estimate distributions of overall survival using the Kaplan-Meier method.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start15 May 2019
- Primary completion19 Nov 2021
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Reported Outcome MeasuresStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aparna Parikh, Massachusetts General Hospital
- Investigators
- Aparna R Parikh, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776837
- Sponsor's protocol ID
- 18-380
- Status last verified
- May 2026
- First submitted
- 30 Jan 2020
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 37976066
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers
- ClinicalTrials.gov ID
- NCT04776837
- Acronym / sponsor ID
- 18-380
- Conditions
- Patient Reported Outcome Measures, Colorectal Cancer, Pancreatic Cancer, Biliary Tract Cancer, Esophageal Cancer, Metastatic Cancer
- Keywords
- Patient Reported Outcome Measures, Colorectal Cancer, Pancreatic Cancer, Biliary Tract Cancer, Esophageal Cancer, Metastatic Cancer, Disease Progression, Survival Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | Behavioral: Observational 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer and receiving anti cancer treatment at Massachusetts General Hospital Cancer Center
Key inclusion criteria (5 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational CohortPatients will be followed by collecting clinical data, biospecimens, and quality of life assessment | Behavioural | Main Cohort |
Primary outcome
Treatment Response at 1st Scan
Time frame: 6 months
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.
11 secondary outcomes
Treatment Response at 1st Scan - Continuous Outcome
Time frame: 6 months
Progression Free Survival - KMC
Time frame: 1 year
Progression Free Survival - HR
Time frame: 1 year
Overall Survival - KMC
Time frame: 1 year
Overall Survival - HR
Time frame: 1 year
ROC Curves
Time frame: 1 year
PROs and Biomarkers as predictor of survival using cox proportional hazards model
Time frame: 6 months
Association between baseline PROs, biomarkers and tumor response
Time frame: 6 months
Associations between baseline PROs, biomarkers, and 6-month survival outcomes
Time frame: 6 months
Sarcopenia Analysis
Time frame: 1 year
Skeletal Muscle Analyses
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publication: PubMed 37976066Jarnagin 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aparna R Parikh, MD, MS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Reported Outcome Measures and Colorectal Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response at 1st Scan (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04776837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.