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Detection of circulating epithelial tumour cells (DETECT)
ISRCTN ISRCTN59722891
DOI 10.1186/ISRCTN59722891
ClinicalTrials.gov identifier
EudraCT number
Public title Detection of circulating epithelial tumour cells (DETECT)
Scientific title A comparison of an antibody-based and an RT-PCR-based technique for the detection of circulating epithelial tumour cells: A multicentre, observational study
Acronym DETECT
Serial number at source DETECT 1
Study hypothesis The aim of this prospective multi-centre trial was to compare the HER2 status of circulating tumour cells (CTCs) in 254 metastatic breast cancer patients at the time of first diagnosis or disease progression obtained by the antibody-based CellSearch® assay and the RT-PCR approach AdnaTest™ Breast Cancer and to assess the concordance rate between these two techniques.
Lay summary Not provided at time of registration
Ethics approval The local institutional review board of the University of Tuebingen, Germany approved on the 26th of September 2007 (ref: 2007/B01).
Study design Prospective multicentre open label non-randomised observational trial
Countries of recruitment Germany
Disease/condition/study domain Metastatic breast cancer
Participants - inclusion criteria 1. Epithelial invasive carcinoma of the breast with distant metastatic disease (M1)
2. Age ≤ 18 years
3. First diagnosis of metastatic disease or disease progression (before start of new treatment regimen)
4. Written informed consent
Participants - exclusion criteria Secondary primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Anticipated start date 01/12/2007
Anticipated end date 01/04/2009
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 254
Interventions Metastatic breast cancer patients were enrolled in this prospective open non-randomized and non-interventional study. Blood was drawn before the start of a new line of therapy.
1. Blood sampling mandatory (one or two times 50mL)
2. Bone marrow aspiration (not mandatory)
Primary outcome measure(s) Rate of HER2 positive CTCs with each method
Secondary outcome measure(s) Concordance between the two methods in (HER2 positive) CTC detection
Sources of funding 1. Institutional funding of participating centres (Germany)
2. Roche Pharma GmbH (Germany)
3. Adnagen GmbH (Germany)
Trial website http://www.detetct-study.de
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20859679
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21745383
Contact name Prof  Tanja  Fehm
  Address Dept of Gynaecology and Obstetrics
Calwer Str 7
  City/town Tuebingen
  Zip/Postcode 72076
  Country Germany
Sponsor University of Tuebingen (Germany)
  Address c/o Prof. Dr. Tanja Fehm
Dept. of Gynaecology and Obstetrics
Calwer Str 7
  City/town Tuebingen
  Zip/Postcode 72076
  Country Germany
Date applied 17/04/2010
Last edited 22/08/2012
Date ISRCTN assigned 04/05/2010
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