Janine Harewood, MD1; Jia Yee, MD1; Henri Tiedge, PhD1; Bret Wankel1; Victoria Forte, MD2; Nora Chokr, MD1; Charles Kim, MD3; Ilham Muslimov, MD, PhD1
1State University of New York (SUNY) Downstate Health Sciences University, Brooklyn, NY
2NYC Health + Hospitals, New York, NY
3NYU Langone Health, New York, NY
Regulatory brain cytoplasmic 200 RNA (BC200 RNA) is a nucleotide RNA transcript found under normal conditions in the brain that inhibits the initiation of translation. It has recently been found to be associated with numerous cancer cells, including human mammary carcinoma cells. Iacoangeli and colleagues previously demonstrated that quantitative reverse-transcription polymerase chain reaction methods could be used as the basis for a blood test for BC200 RNA in patients with invasive breast cancer.1 They were able to demonstrate high sensitivity and specificity of blood levels of BC200 RNA and suggested it could be used as a circulating tumor cell marker (CTC). What is not known is how this marker changes over time and with treatment. Our objective is to investigate how BC200 RNA blood levels in patients with breast cancer correlate with treatment and to establish whether monitoring BC200 RNA in patients’ blood will be useful for evaluating treatment outcomes.
Materials and Methods
We are recruiting all newly diagnosed patients with locally advanced and metastatic breast cancer (aged 18 to 100 years) from the year 2019 and ongoing in a tertiary institution to our study. Treatment interventions are provider dependent. Patients with known genetic conditions are excluded from the study, as are patients who have already had a treatment intervention before the first blood sample was drawn for the study. Blood samples are to be collected at the time of diagnosis, monthly during chemotherapy, after surgery, and every 6 months thereafter. Primary outcomes include assessment of the change in BC200 RNA blood levels over time and with treatment interventions.
The study is open, with ongoing recruitment. Twenty-two participants have been recruited at time of submission. Currently, all patients have had an initial blood sample. Due to COVID-19, follow-up sample collections have been sporadic. One patient has withdrawn from the study and 1 patient has died since starting the study.