Identification of Patients With Age-Related Clonal Hematopoiesis (ARCH) Among Cancer Survivors (ARCH-001)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Monitoring of ARCH variants

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 Type: Observational
• Enrollment (Estimated): 2400

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

• Age ≥ 60

• Completed chemotherapy and/or radiation therapy and are being followed at Princess Margaret Cancer Centre i) Patient must be in remission for > 3 months after completing chemotherapy or radiation ii) Predicted 5 year survival of >75% iii) Peripheral blood counts must have returned to normal as defined by:

  1. Platelets ≥ 100 x 109/L
  2. PMN ≥ 1 x 109/L

Or

• Prior to chemotherapy and/or radiation therapy at the Princess Margaret Cancer Centre.
• All histologically/cytologically proven tumour types (solid tumours and hematologic malignancies) will be eligible.
• Received or will receive regimens of chemotherapy or radiation with doses expected to produce transient myelosuppression (PMN<0.5x109/L) in at least 80% of treated patients (The identification and definition of appropriate myelosuppressive chemotherapy and radiation regimens will be at the discretion of the treating physician and will vary among disease sites).
• Patients must have the ability to understand the requirements of the study and provide written informed consent, which includes authorization for release of protected health information
• Patient must be willing to provide a peripheral blood sample.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Referral to cardiology clinic	6-12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of ARCH stratified by tumor type.	6-12 months

Other Outcome Measures

Outcome Measure	Time Frame
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
The change in VAF pre and post chemotherapy/radiation	6-12 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Christine Chen, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: ARCH
• Other Study ID Numbers: CAPCR 18-5742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There's no plan for data sharing outside of the institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No