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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03878407

Collaborator

(none)

2,400

Enrollment

Location

131.4

Anticipated Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	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 VAF of at least 0.5% we will repeat the genetic sequencing yearly to assess changes in mutational spectrum and VAF over time.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2400 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 18, 2019

Anticipated Primary Completion Date :

Dec 31, 2029

Anticipated Study Completion Date :

Dec 31, 2029

Outcome Measures

Primary Outcome Measures

Referral to cardiology clinic [6-12 months]

Secondary Outcome Measures

The incidence of ARCH stratified by tumor type. [6-12 months]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

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:

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Aaron Schimmer, MD, PhD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03878407

Other Study ID Numbers:

CAPCR 18-5742

First Posted:

Mar 18, 2019

Last Update Posted:

Dec 8, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Health Network, Toronto

ARCH

Study Results

No Results Posted as of Dec 8, 2021