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 design	Prospective multicentre open label non-randomised observational trial
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study acronym	DETECT
Study objectives	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.
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) studied	Metastatic breast cancer
Intervention	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)
Intervention type	Other
Primary outcome measure	Rate of HER2 positive CTCs with each method
Secondary outcome measures	Concordance between the two methods in (HER2 positive) CTC detection
Overall study start date	01/12/2007
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	254
Key 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
Key exclusion criteria	Secondary primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Date of first enrolment	01/12/2007
Date of final enrolment	01/04/2009

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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