Hematopoietic and Lymphatic System NeoplasmNCT06640010
Using Induced-Pluripotent Stem Cells to Model Cancer Therapy-Related Adverse Events
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2025to 15 Dec 2027
- 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: Adult cancer patients who have already started or are planning to start cancer treatment
Who may be able to join
- Any patient >= 18 years of age
- Previously treated, planned or currently receiving any potentially toxic cancer therapy including but not limited to chemotherapy, targeted and immunotherapies
Who cannot join
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
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
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Nadine Norton, PhD
About this study
This study is being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects.
Read the detailed description
PRIMARY OBJECTIVES:
- Generate induced pluripotent stem cells (iPSC's) from patients receiving cancer treatment.
II. Differentiate patient iPSC's into cardiomyocytes and/or neurons or other cell types that may be relevant to modeling cancer therapy-related adverse effects, such as cardiotoxicity and neurotoxicity.
III. Use patient specific iPSC-derived cells to:
IIIa. Model cancer therapy-related toxicities; IIIb. Better understand the mechanisms of toxicities; IIIc. Determine if patient specific genetic variants are causative of toxicities; IIId. Screen novel protective therapies for cancer therapy-related toxicities.
OUTLINE: This is an observational study.
Patients undergo blood sample collection and have their medical records reviewed on study.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood sample collection and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro measurement of cellular viability in response to chemotherapy
Will be compared between cells derived from patients who experienced treatment-induced toxicity to cells derived from patients who received the same cancer therapy without toxicity. Statistical analyses of different endpoints will use Fisher's exact test, one-way ANOVA test followed by all-pairwise-multiple-comparison procedures, or an unpaired, two-tailed Student's t-test with significant differences defined by P < 0.05.
Measured: Blood drawn at enrollment to obtain sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start12 Feb 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Norton, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640010
- Sponsor's protocol ID
- MC240101
- Other IDs
- 24-002830
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2024
- Last updated
- 23 Jun 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Induced-Pluripotent Stem Cells to Model Cancer Therapy-Related Adverse Events
- ClinicalTrials.gov ID
- NCT06640010
- Acronym / sponsor ID
- MC240101
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 15 Oct 2024 (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 being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects.
Detailed description
PRIMARY OBJECTIVES:
- Generate induced pluripotent stem cells (iPSC's) from patients receiving cancer treatment.
II. Differentiate patient iPSC's into cardiomyocytes and/or neurons or other cell types that may be relevant to modeling cancer therapy-related adverse effects, such as cardiotoxicity and neurotoxicity.
III. Use patient specific iPSC-derived cells to:
IIIa. Model cancer therapy-related toxicities; IIIb. Better understand the mechanisms of toxicities; IIIc. Determine if patient specific genetic variants are causative of toxicities; IIId. Screen novel protective therapies for cancer therapy-related toxicities.
OUTLINE: This is an observational study.
Patients undergo blood sample collection and have their medical records reviewed on study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo blood sample collection and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients who have already started or are planning to start cancer treatment
Key inclusion criteria (2 listed)
- Any patient >= 18 years of age
- Previously treated, planned or currently receiving any potentially toxic cancer therapy including but not limited to chemotherapy, targeted and immunotherapies
Key exclusion criteria (1 listed)
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
In vitro measurement of cellular viability in response to chemotherapy
Time frame: Blood drawn at enrollment to obtain sample
Will be compared between cells derived from patients who experienced treatment-induced toxicity to cells derived from patients who received the same cancer therapy without toxicity. Statistical analyses of different endpoints will use Fisher's exact test, one-way ANOVA test followed by all-pairwise-multiple-comparison procedures, or an unpaired, two-tailed Student's t-test with significant differences defined by P < 0.05.
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 23 Jun 2026.
- Mayo Clinic Clinical TrialsLink 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.
Nadine Norton, PhD principal investigator
Mayo Clinic
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 Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic 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 1 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 23 Jun 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vitro measurement of cellular viability in response to chemotherapy (time frame: Blood drawn at enrollment to obtain sample). 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 23 Jun 2026.