ClinicalTrials.gg
Active, not recruitingNCT03878407ARCH-001Updated Feb 3, 2025

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

An observational study in Cancer, sponsored by University Health Network, Toronto. Active, not recruiting at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,400
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer

Browse trials for

Keywords

  • ARCH
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 2,400 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
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

Eligibility criteria

  • 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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherMonitoring 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.

06

What researchers measure

Primary outcomes

  1. Referral to cardiology clinic

    Time frame: 6-12 months

Secondary outcomes

  1. The incidence of ARCH stratified by tumor type.

    Time frame: 6-12 months

Other outcomes

  1. The spectrum of mutations stratified by tumor type.

    Time frame: 6-12 months

  2. The number of patients referred to the ARCH clinic

    Time frame: 6-12 months

  3. The change in VAF over time post chemotherapy/radiation

    Time frame: 6-12 months

  4. The change in VAF pre and post chemotherapy/radiation

    Time frame: 6-12 months

07

Study locations

1 site
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
08

References and documents

Individual participant data

Plan to share: No — There's no plan for data sharing outside of the institution.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03878407
Responsible party
Sponsor
First posted
Mar 18, 2019
Start date
Jan 18, 2019
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 3, 2025

Study contacts

Christine Chen, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion