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NCT Number: NCT03878407

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • 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

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.

Treatment and study plan

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.

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: ARCH-001

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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