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

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ClinicalTrials.gov Identifier: NCT03878407
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
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.

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Study Type : Observational
Estimated 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 : January 18, 2019
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Referral to cardiology clinic [ Time Frame: 6-12 months ]

Secondary Outcome Measures :
  1. The incidence of ARCH stratified by tumor type. [ Time Frame: 6-12 months ]

Other Outcome Measures:
  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 ]

Biospecimen Retention:   Samples With DNA
Peripheral blood


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878407


Contacts
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Contact: Jaime O. Claudio, PhD 416-946-4501 ext 2648 jclaudio@uhnresearch.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Jaime O. Claudio, PhD    416-946-4501 ext 2648    jclaudio@uhnresearch.ca   
Principal Investigator: Aaron Schimmer, MD,PhD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Aaron Schimmer, MD, PhD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03878407    
Other Study ID Numbers: CAPCR 18-5742
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There's no plan for data sharing outside of the institution.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
ARCH