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NCT01722903 · ClinicalTrials.gov registry record
Detection of CTCs in Patients Undergoing Surgery for Stage IV Colorectal Cancer
A clinical trial, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- 25
- Enrollment target
NCT01722903: Completed study, sponsored by Milton S. Hershey Medical Center.
NCT01722903 is a clinical trial that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01722903 has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
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. T
Primary Outcome
Define in which quantity CTCs are retrievable from different blood compartments and lost blood during CRC liver and lung metastases surgery using the Veridex CellSearch system and FMSA filter device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-06 |
What the finished NCT01722903 record still lists
NCT01722903 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01722903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01722903 about?
NCT01722903 is a clinical study titled "Detection of CTCs in Patients Undergoing Surgery for Stage IV Colorectal Cancer". 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 ...
What is the current status of trial NCT01722903?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2012-08. Estimated completion is 2015-06.
Who is sponsoring clinical trial NCT01722903?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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