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

Recruiting

• Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

• Registration Number: NCT06640010
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Study Start: 2025-01-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• * Any patient >= 18 years of age

  • Planned or 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In vitro measurement of cellular viability in response to chemotherapy	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States