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

NCT03878407 | Active Not Recruiting

• 1 other identifier: CAPCR 18-5742
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

ARCH

Outcome Measures

Primary Outcomes (1)

• Referral to cardiology clinic

  6-12 months

Secondary Outcomes (1)

• The incidence of ARCH stratified by tumor type.

  6-12 months

Other Outcomes (4)

• The spectrum of mutations stratified by tumor type.

  6-12 months

• The number of patients referred to the ARCH clinic

  6-12 months

• The change in VAF over time post chemotherapy/radiation

  6-12 months

Interventions

Monitoring of ARCH variants OTHER

Blood samples will be tested for mutations, before patients are given Standard of Care chemotherapy/radiation or after given Standard of Care chemotherapy/radiation. Another testing is done after 3 months and after 1 year if positive for ARCH.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Neoplasms

Study Officials

• Christine Chen, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: January 18, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)