Status:
ACTIVE_NOT_RECRUITING
Identification of Patients With Age-Related Clonal Hematopoiesis (ARCH) Among Cancer Survivors
Lead Sponsor:
University Health Network, Toronto
Conditions:
Cancer
Eligibility:
All Genders
60+ years
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 c...
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 ther...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT03878407
Start Date
January 18 2019
End Date
December 31 2029
Last Update
February 3 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9