DNA Methylation in Serum as a Predictive Marker of Progression and Survival Following Systemic Therapy in Patients With Metastatic Breast Cancer
- Identify a panel of methylated gene markers in serum from women with metastatic breast
cancer that is significantly different from that observed in healthy participants.
- Assess changes in a panel of methylated gene markers from baseline, after 3-4 weeks,
and after 9-12 weeks of systemic therapy in patients with metastatic breast cancer.
- Determine the potential effects of common exposures (i.e., alcohol, smoking,
medications, and dietary factors) on patterns of serum methylation in patients with
metastatic breast cancer and in healthy participants.
- Develop a predictive model using DNA methylation profiles in serum that predicts
clinical outcome for an individual patient with metastatic disease.
- Correlate circulating tumor cells (CTCs) with clinical outcome in patients with
metastatic breast cancer.
- Correlate CTCs with serum methylation in these patients.
- Determine if the addition of CTCs to serum methylation results in an improved
OUTLINE: This is a prospective, multicenter study.
Patients and healthy participants fill out health assessment questionnaires at baseline,
week 3-4, and week 9-12.
Patients undergo blood collection for methylated marker analysis at baseline, weeks 3-4, and
weeks 9-12 and circulating tumor cell levels at baseline and weeks 3-4. Healthy participants
undergo blood collection for methylated marker analysis at baseline. An additional cohort of
healthy participants undergo follow-up blood collection ≥ 1 week after baseline.
DNA methylation is measured by quantitative multiplex methylation-specific polymerase chain
reaction (QM-MSP) assay.
After completion of study procedures, patients are followed every 3-4 months.
PROJECTED ACCRUAL: A total of 150 patients and 150 healthy participants will be accrued for
Observational Model: Cohort, Time Perspective: Prospective
Correlation of changes in gene marker methylation with progression at 9-12 weeks
Antonio C. Wolff, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|