Identification of Patients With Age-Related Clonal Hematopoiesis (ARCH) Among Cancer Survivors

Active, not recruiting

• Conditions: Cancer

• Registration Number: NCT03878407
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this study is to see if patients with cancer have a certain amount of genetic mutations in their blood. If certain levels of mutations are found in specific genes, patients may have a condition known as ARCH. The prevalence of ARCH is higher in cancer patients who received prior chemotherapy or radiation. Studying ARCH from your blood samples may also help researchers predict which patients are more likely to be prone to heart disease. Patients who are about to start chemotherapy/radiation, and patients who have completed chemotherapy/radiation will be approached to measure the incidence of ARCH. 5-10mL blood samples will be collected before and after treatment, and if ARCH is detected in a laboratory analysis, another blood sample will be collected. Patients with ARCH will repeat the blood collection yearly, and also be referred to a cardiology clinic for follow up.

Detailed Description

This is a non-randomized, single-centre, observational study assessing the incidence of ARCH in cancer survivors. Patients over the age of 60 who had or will receive chemotherapy and/or radiation therapy for solid or hematologic malignancies at the Princess Margaret Cancer Centre will be considered. Based on the time point of treatment, patients will either fall into a post or prior chemotherapy/radiation cohort. Peripheral blood will be taken and will be sequenced for ARCH DNA mutations. Patients who have ARCH-related mutations at a variable allele frequency (VAF) of at least 0.5% we will repeat the genetic sequencing yearly to assess changes in mutational spectrum and VAF over time.

Study Timeline

• Study Start: 2019-01-18
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

Not provided

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Exclusion Criteria

• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Referral to cardiology clinic	6-12 months

Secondary Outcome Measures

Name	Time	Method
The incidence of ARCH stratified by tumor type.	6-12 months

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada