TumorNCT07382752
Decoupling Immunotherapy Toxicity and Cancer Response
An observational study of Tumor and Cardiovascular, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study is a novel evaluation of cardiotoxicity after ICI therapy based on traditional CV risk factors with the addition of metabolomic profiles, epigenetic aging, and CHIP. It is not an extension of previous work in ICI therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Cardiovascular
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 30 Jun 2030
- 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: MD Anderson Cancer Center
Who may be able to join
- Age ≥ 18 years
- Plan to start immune checkpoint inhibitor for cancer therapy
Who cannot join
- No baseline blood collection prior to initiation
- At time of evaluation not determined to be a good candidate for evaluation of outcome events by the principal investigator
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
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Nicolas Palaskas, MD, 832-750-1109, nlpalaskas@mdanderson.org
Nicolas Palaskas, MD
About this study
Official title: Metabolomic and Genetic Factors Decoupling Immune Checkpoint Inhibitor Tumor Efficacy and Cardiovascular Toxicity
This study is a novel evaluation of cardiotoxicity after ICI therapy based on traditional CV risk factors with the addition of metabolomic profiles, epigenetic aging, and CHIP. It is not an extension of previous work in ICI therapy.
Read the detailed description
Primary Objectives:
To identify predictors of a composite outcome comprising immune checkpoint inhibitor associated cardiovascular disease (ICI-CVD) and/or cancer progression or death.
To decouple the predictors of ICI-CVD and cancer treatment efficacy.
Secondary Objectives:
To identify human monocyte derived macrophages (HMDM)-derived metabolite signatures predictive of cardiovascular toxicity and cancer outcomes in ICI-treated patients.
To identify genetic (CHIP) and epigenetic age determinants of ICI-CVD and cancer outcomes in ICI-treated patients.
- Conditions
- Tumor, Cardiovascular
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Observational Cohort | Utilizing baseline biospecimens for analysis of predictors of cardiotoxicity events and cancer outcomes after ICI initiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start9 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Palaskas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382752
- Sponsor's protocol ID
- 2025-1571
- Other IDs
- NCI-2025-09341
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2026
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic and Genetic Factors Decoupling Immune Checkpoint Inhibitor Tumor Efficacy and Cardiovascular Toxicity
- ClinicalTrials.gov ID
- NCT07382752
- Acronym / sponsor ID
- 2025-1571
- Conditions
- Tumor, Cardiovascular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 3 Feb 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.
This study is a novel evaluation of cardiotoxicity after ICI therapy based on traditional CV risk factors with the addition of metabolomic profiles, epigenetic aging, and CHIP. It is not an extension of previous work in ICI therapy.
Detailed description
Primary Objectives:
To identify predictors of a composite outcome comprising immune checkpoint inhibitor associated cardiovascular disease (ICI-CVD) and/or cancer progression or death.
To decouple the predictors of ICI-CVD and cancer treatment efficacy.
Secondary Objectives:
To identify human monocyte derived macrophages (HMDM)-derived metabolite signatures predictive of cardiovascular toxicity and cancer outcomes in ICI-treated patients.
To identify genetic (CHIP) and epigenetic age determinants of ICI-CVD and cancer outcomes in ICI-treated patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Observational Cohort | – | –Utilizing baseline biospecimens for analysis of predictors of cardiotoxicity events and cancer outcomes after ICI initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Plan to start immune checkpoint inhibitor for cancer therapy
Key exclusion criteria (2 listed)
- No baseline blood collection prior to initiation
- At time of evaluation not determined to be a good candidate for evaluation of outcome events by the principal investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 16 Jul 2026.
- MD Anderson Cancer Center WebsiteLink 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.
Nicolas Palaskas, MD principal investigator
M.D. Anderson Cancer Center
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 Tumor and Cardiovascular, run by M.D. Anderson Cancer Center 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 2 inclusion and 2 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 16 Jul 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 Nicolas Palaskas, MD (832-750-1109, nlpalaskas@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 16 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.