Detection of circulating epithelial tumour cells (DETECT)
| ISRCTN | ISRCTN59722891 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59722891 |
| Protocol serial number | DETECT 1 |
| Sponsor | University of Tuebingen (Germany) |
| Funders | Institutional funding of participating centres (Germany), Roche Pharma GmbH (Germany), Adnagen GmbH (Germany) |
- 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
Contact information
Prof Tanja Fehm
Scientific
Scientific
Dept of Gynaecology and Obstetrics
Calwer Str 7
Tuebingen
72076
Germany
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective multicentre open label non-randomised observational trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Rate of HER2 positive CTCs with each method |
| Key secondary outcome measure(s) |
Concordance between the two methods in (HER2 positive) CTC detection |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
72076
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
