Detection of CTCs in Patients Undergoing Surgery for Stage IV Colorectal Cancer

Completed

Conditions studied: Stage IV Colorectal Cancer, Liver Metastases, Lung Metastases

In brief

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.

Key facts

Study ID

NCT01722903

Run by

Milton S. Hershey Medical Center

People needed

25

Starts

2012-08-01

Expected to finish

2015-06-01

Last updated by the study team

2016-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects older than 18 years will be included.
• Subjects with colorectal primary carcinomas metastatic to the liver and/or lungs who will undergo a synchronous resection of both primary tumor and liver metastases will also be enrolled.
• Subjects of all genders and ethnicities will be included.
• Subjects with the diagnosis of stage IV primary CRC will be included if metastases are limited to liver and/or lungs at the time of primary surgery.
• The histopathology of the CRC primary tumor must be documented to be adenocarcinoma.
• Subjects with the diagnosis of syn- and metachronous liver and/or lung metastases from colorectal carcinoma will be included, as long as metastases at both sites are resectable by minimal invasive or conventional approach (usually sequentially and not simultaneously).
• Liver and lung metastases must be defined according to radiological criteria. In case of doubt on radiologic findings, percutaneous biopsy will have to be obtained.
• Subjects must be capable of giving informed consent or have an acceptable surrogate capable of giving legally authorized consent on the subject's behalf.

You may not qualify if…

• Subjects with the concurrent diagnosis of an active second malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or the patient is currently treated with chemotherapy.
• Subjects with a Hemoglobin of <8g/dl in the morning of the procedure will be excluded.
• In subjects who had needed intraoperative transfusions >4 units of RPBCs, no further blood will be drawn for CTC analysis.
• Pregnant women will be excluded.

Where it is running

• MS Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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