Plain English Summary
Not provided at time of registration
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
DETECT 1
Study information
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
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.
Ethics approval(s)
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
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Study setting(s)
Other
Study type
Diagnostic
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Overall study end date
01/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
254
Participant exclusion criteria
Secondary primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Recruitment start date
01/12/2007
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Germany
Study participating centre
Dept of Gynaecology and Obstetrics
Tuebingen
72076
Germany
Sponsor information
Organisation
University of Tuebingen (Germany)
Sponsor details
c/o Prof. Dr. Tanja Fehm
Dept. of Gynaecology and Obstetrics
Calwer Str 7
Tuebingen
72076
Germany
Sponsor type
University/education
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Institutional funding of participating centres (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Roche Pharma GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Adnagen GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |