Detection of circulating epithelial tumour cells (DETECT)

ISRCTN ISRCTN59722891
DOI https://doi.org/10.1186/ISRCTN59722891
Secondary identifying numbers DETECT 1
Submission date
17/04/2010
Registration date
04/05/2010
Last edited
22/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Tanja Fehm
Scientific

Dept of Gynaecology and Obstetrics
Calwer Str 7
Tuebingen
72076
Germany

Study information

Study designProspective multicentre open label non-randomised observational trial
Primary study designObservational
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleA comparison of an antibody-based and an RT-PCR-based technique for the detection of circulating epithelial tumour cells: A multicentre, observational study
Study acronymDETECT
Study objectivesThe 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.
Ethics approval(s)The local institutional review board of the University of Tuebingen, Germany approved on the 26th of September 2007 (ref: 2007/B01).
Health condition(s) or problem(s) studiedMetastatic breast cancer
InterventionMetastatic 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)
Intervention typeOther
Primary outcome measureRate of HER2 positive CTCs with each method
Secondary outcome measuresConcordance between the two methods in (HER2 positive) CTC detection
Overall study start date01/12/2007
Completion date01/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants254
Key inclusion criteria1. 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
Key exclusion criteriaSecondary primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Date of first enrolment01/12/2007
Date of final enrolment01/04/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

Dept of Gynaecology and Obstetrics
Tuebingen
72076
Germany

Sponsor information

University of Tuebingen (Germany)
University/education

c/o Prof. Dr. Tanja Fehm
Dept. of Gynaecology and Obstetrics
Calwer Str 7
Tuebingen
72076
Germany

ROR logo "ROR" https://ror.org/03a1kwz48

Funders

Funder type

Hospital/treatment centre

Institutional funding of participating centres (Germany)

No information available

Roche Pharma GmbH (Germany)

No information available

Adnagen GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2010 Yes No
Results article results 11/07/2011 Yes No