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NCT Number: NCT06640010

Using Induced-Pluripotent Stem Cells to Model Cancer Therapy-Related Adverse Events

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.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Nadine Norton, PhD

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

I. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Inability on the part of the patient to understand the informed consent or be compliant with the protocol

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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