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AdnaTest BreastCancer information for medical professionals (Swedish) Detection and Molecular Profiling of Circulating Tumor Cells in Patients with Primary Ovarian Cancer Validation of AdnaTest BreastCancer BR-01-2004 "Detection of circulating tumour cells in breast cancer: Performance evaluation study ofthe CE-marked in vitro diagnostic medical device AdnaTest BreastCancer"
1. Aims This study is performed to determine -the prognostic value of the AdnaTest BreastCancer byanalyzing breast cancer patients over a period of three years. - to evaluate efficacy of neoadjuvant therapy by analyzing breast cancer patients prior and after therapy administration. 2. Study Design  Study Design BR-01-2004Non-randomised, open, multicenter study 3. Cooperating Centers To date patients are recruited one center: University of Tübingen, Germany, Gynecological Hospital - Prof. Dr. E.-F.Solomayer, Prof. Wallwiener Recruitment and data collection are completed. Data analysis is in progress.
BR-01-2005 "Determinationof HER2-antigen in serum of initially HER2-negative metastasized breast cancerpatients" (With considerationof the HER2 mRNA expression of circulating tumor cells.) 1. Aim This pilot type study is performed to determine the prognostic value of the AdnaTest BreastCancer in CTC as non-invasive diagnostic to predict clinical prognosis in advanced breast cancer and in addition to provide a decision guidance for therapy administration with Herceptin. 2. Features Patients are recruited in a single center. Inclusion criteria are advancedbreast cancer (M1) with initially HER2 negative or HER2 unknown primary tumor. Patient data are processed as follows: not regulated (ICH-GCP), non-randomised,open labeled and prospective. HER2mRNA expression in circulating tumor cells is analyzed by the AdnaTest BreastCancer.
3. Cooperating Center University of Tübingen, Germany, Gynecological Hospital - Prof. Dr. E.-F.Solomayer, Prof. Dr. T. Fehm Recruitment and data collection are completed. Results are published.
BR-01-2007
"Detectionof circulating tumor cells as a predictive factor in therapy monitoring"
BR-02-2007 "EMTand stem cell characteristics of circulating tumor cells"
Validation of AdnaTest ColonCancer
CO-03-2004 "Detection of circulating tumor cells frommetastasized 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 cancerpatients 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 orulcerative 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 orulcerative colitis. Patient data are processed as follows: not regulated(ICH-GCP), non-randomised, open labeled and prospective. 3. CooperatingCenter Medical School Hannover, Germany, Dept.Gastroenterology and Hepatology - Prof. Dr. T. Greten Collection ofblood samples since 10/2004. Recruitment and data analysis are completed. Results will be published.
"Characterizationof EGFR expression on circulating tumor cells in the peripheral blood ofcolorectal cancer patients"
1. Aim
EGFR is a target for several new drugs like therapeutic antibodies and low MWsignal transduction inhibitors which are promising tools in optimized and individualized cancer therapy. This pilot type study is performed to characterize EGFR on circulating tumorcells to provide a new diagnostic as guidance in therapy decision and drugapplication. In addition this study will confirm the relevance of circulatingtumor 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. Patientdata are processed as follows: not regulated (ICH-GCP), non-randomised, openlabeled and prospective.
3. Cooperating Center Medical SchoolHannover, Germany, Dept. Gastroenterology and Hepatology - Prof. Dr. T. Greten Recruitment and data analysis are completed. Results will bepublished. |