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

Cancer Clinical Trial

— ARCH-001  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03878407
• Other study ID #: CAPCR 18-5742
• Status: Active, not recruiting
• Start date: January 18, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2400
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Gender: All
• Age group: 60 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Monitoring of ARCH variants
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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The spectrum of mutations stratified by tumor type.		6-12 months
Other	The number of patients referred to the ARCH clinic		6-12 months
Other	The change in VAF over time post chemotherapy/radiation		6-12 months
Other	The change in VAF pre and post chemotherapy/radiation		6-12 months
Primary	Referral to cardiology clinic		6-12 months
Secondary	The incidence of ARCH stratified by tumor type.		6-12 months