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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Stage IV Colorectal Cancer, Liver Metastases or Lung Metastases
and you are
over 18
years old
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States. About 90% of CRC related deaths are due to metastatic spread—mostly to the liver and lungs. With adequate multidisciplinary patient selection, CRC liver and lung metastasectomy significantly improves survival and offers the best chance for a cure. However, patients with limited lung or liver metastases are clinically underserved and poorly scientifically studied. The individual indication for resection and the decision making for adjuvant systemic therapies remains a challenge. More sensitive techniques to detect occult disease are needed for metastatic CRC (mCRC) patients, and perioperative analysis of circulating tumor cells (CTCs) may provide an outstanding opportunity to develop such innovative methods. We hypothesize that CTCs are enriched during CRC liver and/or lung metastasectomy, and that they can be isolated and characterized in an attempt to identify novel therapeutic targets. CTCs are believed to be causing metastasis and may provide a non-invasive alternative to organ biopsies for the detection, characterization and monitoring of solid cancers. CTC numbers have been shown to be a strong predictor of Progression Free Survival and Overall Survival for mCRC patients. The CellSearch system (Veridex LLC, Ratinas, NJ, USA) currently is the only FDA approved test for the evaluation of CTC numbers in metastatic breast, prostate and colorectal cancer. However, the rarity of CTCs in the blood leads to limited capture efficiency and the CellSearch system fixes cells, preventing further molecular characterization of CTCs by functional assays and primary cell culture. In this protocol the CellSearch system will be compared to a new technology, called the Flexible Micro Spring Array (FMSA) device, developed by Dr. Zheng, Department of Bioengineering, Penn State University, University Park. This novel approach enables size-exclusion based filtration for viable CTC enrichment. The FMSA device is inexpensive, works rapidly, and retains viable CTCs for further biological study. Using both the CellSearch system and the FMSA device, we will determine the kinetics of CTC shedding into circulation, develop an effective system for isolation, enumeration, and further enrichment CTCs, and use this system to find characteristics of different CTC populations.

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01722903. The sponsor of the trial is Milton S. Hershey Medical Center and it is looking for 25 volunteers for the current phase.
Official trial title:
Perioperative Detection and Characterization of Circulating Tumor Cells in Patients Undergoing Colorectal Cancer Liver and Lung Metastasectomy