High Definition Single Cell Analysis in Colorectal Cancer
Description
Brief Summary
This research clinical trial studies high definition single cell analysis in blood and tissue
samples from patients with colorectal cancer which has spread to the liver. High definition
single cell analysis allows doctors to study the properties of cancer cells that are
sometimes found in the blood of patients and to determine how the genes and proteins in them
may change over time. Studying samples from patients with colorectal cancer in the laboratory
may help doctors learn more about how cancer spreads, as well as how to predict the disease
outcomes in patients with cancer.
Detailed Description
I. To determine the level of correlation between solid tumor touch preparations and liquid
biopsies (circulating tumor cells [CTCs]) from patients with surgically resected colorectal
cancer (CRC) metastases to the liver using single-cell high-content analysis, including gene
copy number variation (CNV) and to establish one or more bio-signatures that represent the
liquid and solid biopsy correlation for each patient and for the patient population.
SECONDARY OBJECTIVES:
I. To demonstrate the technical validity and reproducibility of the bio-signatures by
comparing the two pre-resection liquid biopsy samples drawn one week prior to and on the day
of surgery.
TERTIARY OBJECTIVES:
I. Compare biosignatures between pre-surgical and post-surgical blood samples. II. Compare
biosignatures between resected metastatic liver tumor tissue, primary colon tumor tissue (if
available), and pre-surgical blood samples.
III. Compare biosignatures between blood samples prior to resection with those obtained after
resection and at the time of recurrence.
OUTLINE:
Patients undergo blood collection 1 week prior surgery, before and after surgery on the same
day, and 1 week and 3 months after surgery. Patients also undergo tissue collection during
the surgery. Blood and tissue samples are processed for high definition single cell analysis
including whole-genome CNV profiles, protein expression, and cell morphology.
After completion of study, patients are followed up for up to 2 years.
Phase
N/AInclusion and Exclusion Criteria
- Able to provide informed consent
- Metastatic colorectal adenocarcinoma to the liver (hepatic mCRC)
- Synchronous or metachronous
- Solitary or multifocal
- Concurrent abdominal lymph node metastasis is allowable
- Hepatic mCRC deemed surgically resectable by the study team with plans to undergo surgery
- Has not received any systemic chemotherapy for at least 21 days prior to scheduled hepatic resection
- Non-adenocarcinoma metastatic colorectal cancer (e.g. neuroendocrine carcinoma); mucinous component is permitted
- Metastatic CRC that involves organ(s)/tissue(s) other than abdominal lymph nodes and/or liver
- Has received any systemic chemotherapy within 21 days prior to scheduled hepatic resection
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Powered by
SC CTSI