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Validation of AdnaTest ColonCancer

CO-03-2004

"Detection of circulating tumor cells from metastasized colorectal cancer patients"

1. Aim
This pilot type study is performed to determine the predictive value of the AdnaTest ColonCancer in evaluating efficacy of cancer therapy. Colon cancer patients with advanced disease and metastasizing tumors were chosen on the assumption to have elevated numbers of circulating tumor cells in their peripheral blood. Successful therapy should lead to decreased numbers of circulating tumor cells yielding a negative AdnaTest result.
Diseases discussed as possible precanceroses are included as well, i.e. patients with inflammatory gastrointestinal diseases like Crohn's disease or ulcerative colitis, to evaluate the specificity of the AdnaTest ColonCancer.
2. Features
Patients are recruited in a single center. Inclusion criteria are advanced colorectal cancer (M1) and patients suffering from Crohn's disease or ulcerative colitis. Patient data are processed as follows: not regulated (ICH-GCP), non-randomised, open labeled and prospective.
3. Cooperating Center
Medical School Hannover, Germany, Dept. Gastroenterology and Hepatology - Prof. Dr. T. Greten

Collection of blood samples since 10/2004. Recruitment and data analysis are completed. Results will be published.

Circulating tumour cells as a predictive factor for response to systemic chemotherapy in patients with advanced colorectal cancer   >>Download

CO-01-2005

"Characterization of EGFR expression on circulating tumor cells in the peripheral blood of colorectal cancer patients"

1. Aim
EGFR is a target for several new drugs like therapeutic antibodies and low MW signal transduction inhibitors which are promising tools in optimized and individualized cancer therapy.
This pilot type study is performed to characterize EGFR on circulating tumor cells to provide a new diagnostic as guidance in therapy decision and drug application. In addition this study will confirm the relevance of circulating tumor cells as indicator of the situation of the patient which might reflect much better the patient´s status than immunohistological analysis of the formerly resected primary tumor.
2. Features
Patients are recruited in a single center. Inclusion criteria are advanced colorectal cancer (M1), with surgically resectable liver metastases. Patient data are processed as follows: not regulated (ICH-GCP), non-randomised, open labeled and prospective.
3. Cooperating Center
Medical School Hannover, Germany, Dept. Gastroenterology and Hepatology - Prof. Dr. T. Greten

Recruitment and data analysis are completed. Results will be published.

Tumour-associated transcripts and EGFR deletion variants in colorectal cancer in primary tumour, metastases and circulating tumour cells   >>Download