Advanced Colorectal CarcinomaUNCOVERNCT07776353
Understanding New Cachexia Subtypes Through Observational Epidemiological Research
An observational study of Advanced Colorectal Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by Kaiser Permanente at 1 site in United States.
Trial summary
The UNCOVER study is a longitudinal observational cohort focused on patients at high risk for cancer cachexia. At Kaiser Permanente Northern California, up to 800 individuals with advanced or unresectable non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer will be enrolled, as these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Electronic health record review
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to May 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, or colorectal cancer.
Who may be able to join
- Have a primary diagnosis of unresectable or Stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer (CRC).
- Note: Patients do not need to have cachexia to be eligible
- Plan to start first line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
- Note: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant therapy and have since recurred are still eligible if such treatment was longer than 6 months prior to enrollment.
- Have an an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Be able to understand, speak and read English.
- Be 18 years or older
Who cannot join
- Have contraindications to physical function assessments (30-second bicep curl, Timed-Up-And-Go test, or 30-Second Sit to Stand test) per the treating provider or their designee.
- Have any planned major surgeries within the next 3 months after enrollment to the best knowledge of the investigator/treating provider or their designee.
- Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than non-melanoma skin cancer.
- Be pregnant or within 6 months postpartum.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente Northern California
Pleasanton, California, 94588
Michelle C Ross, MPH, (925) 520-0650, michelle.c.ross@kp.org
About this study
The UNCOVER study is a longitudinal observational cohort focused on patients at high risk for cancer cachexia. At Kaiser Permanente Northern California, up to 800 individuals with advanced or unresectable non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer will be enrolled, as these malignancies carry a substantial risk of cancer cachexia, which is characterized by progressive loss of weight, muscle, and adipose tissue, accompanied by functional decline and reduced quality of life. Data collected includes demographic, physiologic, and clinical data, including tumor characteristics and biomarkers of inflammation, hormonal and metabolic status, body composition, physical function, and patient reported outcomes. Investigators will identify patient phenotypes (i.e., subgroups) that may reflect distinct biological or clinical pathways underlying cancer cachexia. By characterizing heterogeneity in cancer cachexia, this study aims to inform the development of improved diagnostic criteria and more targeted therapeutic strategies, ultimately enhancing clinical trial design and supportive care for patients with advanced colorectal, lung, or pancreatic cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify multiple distinct diagnostic phenotypes within the syndrome of cancer cachexia as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for cancer cachexia.
II. To determine the association of each cancer cachexia phenotype with overall survival.
SECONDARY OBJECTIVES:
- To determine the association of each cancer cachexia phenotype with functional decline and treatment intolerance.
II. To inform clinical practice guidelines for prompt recognition of patients likely to progress to refractory cachexia, identify early predictors apparent at clinical presentation of each cancer cachexia phenotype defined in the primary objective.
- Conditions
- Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Electronic health record review, Medical Device Usage and Evaluation, Physical functions assessments
- Keywords
- Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases, Respiratory Tract Neoplasms, Thoracic Neoplasms, Lung Diseases, Respiratory Tract Diseases, Endocrine Gland Neoplasms, Pancreatic Diseases, Endocrine System Diseases, Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood and archived tumor samples. A sub-sample undergo collection of stool samples.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT or PET/CT scan
Electronic health record reviewOther
Electronic Health Record Review
Medical Device Usage and EvaluationOther
Wear actigraph
Physical functions assessmentsOther
Also called Physical Fitness Testing, Physical Function Testing
Undergo physical function assessments including 30-second bicep curl, timed up and go (TUG), and 30-second sit to stand
Positron Emission Tomography (PET)Procedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT scan
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey, function tests, biospecimen, actigraphy) | Patients complete surveys, undergo physical function tests, undergo collection of blood and archived tumor samples, and wear an actigraph over 24 hours for a week to record daily sleep and exercise activity at baseline and 3-month follow-up. A sub-sample of patients provide stool samples. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic health record review; Other: Medical Device Usage and Evaluation; Other: Physical functions assessments; Procedure: Positron Emission Tomography (PET); Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple distinct diagnostic cancer cachexia phenotypes
Phenotypes will be based on patient-reported symptoms, physical activity and function assessments, biomarkers, and body composition measured longitudinally using latent class analysis and other clustering methods.
Measured: Baseline through study completion, assessed up to 1 year follow up
Overall survival: time to death
Time to death will be assessed as the interval between phenotype ascertainment and death from any cause. Participants without a recorded death event will be censored at the end of available follow-up (e.g., end of health plan membership or the study observation period).
Measured: Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up
Secondary outcomes (3)
Functional decline
Associations between each cancer cachexia phenotype and functional decline is a secondary outcome. Functional status will be measured at baseline and study completion by physical function assessments and patient-reported questionnaires.
Measured: Baseline through study completion, assessed up to 1 year follow up
Treatment intolerance
Treatment intolerance will be modeled as time to event outcomes. Treatment data including chemotherapy, targeted therapy, and immunotherapy will be obtained from the electronic medical record.
Measured: Baseline through study completion, assessed up to 1 year follow up
Early predictors of decline
Logistic regression will be used to identify patient characteristics apparent at clinical presentation that are early predictors of each cancer cachexia phenotype, focusing on the high-risk phenotypes that are associated with poor outcomes.
Measured: Baseline through study completion, assessed up to 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start5 Apr 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CarcinomaStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Research UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776353
- Sponsor's protocol ID
- 1927206
- Other IDs
- OT2CA278691, CGCATF-2021/100033
- Acronym
- UNCOVER
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding New Cachexia Subtypes Through Observational Epidemiological Research
- ClinicalTrials.gov ID
- NCT07776353
- Acronym / sponsor ID
- UNCOVER / 1927206
- Conditions
- Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Keywords
- Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Research UK
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 Aug 2026 (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.
The UNCOVER study is a longitudinal observational cohort focused on patients at high risk for cancer cachexia. At Kaiser Permanente Northern California, up to 800 individuals with advanced or unresectable non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer will be enrolled, as these malignancies carry a substantial risk of cancer cachexia, which is characterized by progressive loss of weight, muscle, and adipose tissue, accompanied by functional decline and reduced quality of life. Data collected includes demographic, physiologic, and clinical data, including tumor characteristics and biomarkers of inflammation, hormonal and metabolic status, body composition, physical function, and patient reported outcomes. Investigators will identify patient phenotypes (i.e., subgroups) that may reflect distinct biological or clinical pathways underlying cancer cachexia. By characterizing heterogeneity in cancer cachexia, this study aims to inform the development of improved diagnostic criteria and more targeted therapeutic strategies, ultimately enhancing clinical trial design and supportive care for patients with advanced colorectal, lung, or pancreatic cancer.
Detailed description
PRIMARY OBJECTIVES:
- To identify multiple distinct diagnostic phenotypes within the syndrome of cancer cachexia as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for cancer cachexia.
II. To determine the association of each cancer cachexia phenotype with overall survival.
SECONDARY OBJECTIVES:
- To determine the association of each cancer cachexia phenotype with functional decline and treatment intolerance.
II. To inform clinical practice guidelines for prompt recognition of patients likely to progress to refractory cachexia, identify early predictors apparent at clinical presentation of each cancer cachexia phenotype defined in the primary objective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey, function tests, biospecimen, actigraphy) | – | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic health record review, Other: Medical Device Usage and Evaluation, Other: Physical functions assessments, Procedure: Positron Emission Tomography (PET), Other: Survey AdministrationPatients complete surveys, undergo physical function tests, undergo collection of blood and archived tumor samples, and wear an actigraph over 24 hours for a week to record daily sleep and exercise activity at baseline and 3-month follow-up. A sub-sample of patients provide stool samples. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, or colorectal cancer.
Key inclusion criteria (7 listed)
- Have a primary diagnosis of unresectable or Stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer (CRC).
- Note: Patients do not need to have cachexia to be eligible
- Plan to start first line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
- Note: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant therapy and have since recurred are still eligible if such treatment was longer than 6 months prior to enrollment.
- Have an an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Key exclusion criteria (4 listed)
- Have contraindications to physical function assessments (30-second bicep curl, Timed-Up-And-Go test, or 30-Second Sit to Stand test) per the treating provider or their designee.
- Have any planned major surgeries within the next 3 months after enrollment to the best knowledge of the investigator/treating provider or their designee.
- Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than non-melanoma skin cancer.
- Be pregnant or within 6 months postpartum.
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood and archived tumor samples. A sub-sample undergo collection of stool samples. | Procedure or surgery | Observational (survey, function tests, biospecimen, actigraphy) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT or PET/CT scan | Procedure or surgery | Observational (survey, function tests, biospecimen, actigraphy) |
| Electronic health record reviewElectronic Health Record Review | Other | Observational (survey, function tests, biospecimen, actigraphy) |
| Medical Device Usage and EvaluationWear actigraph | Other | Observational (survey, function tests, biospecimen, actigraphy) |
| Physical functions assessmentsAlso: Physical Fitness Testing, Physical Function TestingUndergo physical function assessments including 30-second bicep curl, timed up and go (TUG), and 30-second sit to stand | Other | Observational (survey, function tests, biospecimen, actigraphy) |
| Positron Emission Tomography (PET)Also: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT scan | Procedure or surgery | Observational (survey, function tests, biospecimen, actigraphy) |
| Survey AdministrationComplete surveys | Other | Observational (survey, function tests, biospecimen, actigraphy) |
Primary outcome
Multiple distinct diagnostic cancer cachexia phenotypes
Time frame: Baseline through study completion, assessed up to 1 year follow up
Phenotypes will be based on patient-reported symptoms, physical activity and function assessments, biomarkers, and body composition measured longitudinally using latent class analysis and other clustering methods.
Overall survival: time to death
Time frame: Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up
Time to death will be assessed as the interval between phenotype ascertainment and death from any cause. Participants without a recorded death event will be censored at the end of available follow-up (e.g., end of health plan membership or the study observation period).
3 secondary outcomes
Functional decline
Time frame: Baseline through study completion, assessed up to 1 year follow up
Treatment intolerance
Time frame: Baseline through study completion, assessed up to 1 year follow up
Early predictors of decline
Time frame: Baseline through study completion, assessed up to 1 year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Related InfoLink provided by the sponsor.
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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.
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 Advanced Colorectal Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by Kaiser Permanente 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth M Cespedes Feliciano, ScD, SM ((510) 414-4154, Elizabeth.M.Cespedes@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple distinct diagnostic cancer cachexia phenotypes (time frame: Baseline through study completion, assessed up to 1 year follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.