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

NCT06640010 | Recruiting

• 3 other identifiers: MC240101NCI-2024-0835524-002830
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Blood drawn at enrollment to obtain sample

Study Arms (1)

Observational

Patients undergo blood sample collection and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cancer patients who have already started or are planning to start cancer treatment

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Nadine Norton, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (1)