Clonal Hematopoiesis as a Marker of Genetic Damage Following Adjuvant Chemotherapy for Breast Cancer: Pilot Study to Evaluate Incidence
Abstract
A serious late complication associated with breast cancer treatment is the increased risk for development of therapy-related hematologic malignancies. The goal of this biologic study is to determine whether dose-intensive adjuvant regimens for breast cancer induce genetic damage to hematopoietic stem cells, defined by the emergence of clonal hematopoiesis. Clonal hematopoiesis has been proposed as an early marker of hematopoietic stem cell damage, preceding the acquisition of critical, recurring genetic alterations associated with the development of therapy-related myelodysplastic syndromes and acute leukemia. Clonal hematopoiesis is being evaluated by two different methods, the X-linked HUMARA clonality and microsatellite instability assays. Positive clones will be further analyzed for MLL and RAS alterations. Study accomplishments to date: a) ancillary biological protocol (S97l9) written and approved for study; b) clonality assays developed and standardized; c) specimen collection and data analysis of 188 samples from 29 patients completed; d) preliminary approval granted to incorporate S9719 into a new clinical treatment protocol, S0012; and e) submitted protocol revisions to DOD and CTEP on 8/23/01, awaiting final approval prior to study implementation.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2001
- Accession Number
- ADA398181
Entities
People
- Charles A. Coltman Jr.