Condition category
Cancer
Date applied
17/04/2010
Date assigned
04/05/2010
Last edited
22/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.detetct-study.de

Contact information

Type

Scientific

Primary contact

Prof Tanja Fehm

ORCID ID

Contact details

Dept of Gynaecology and Obstetrics
Calwer Str 7
Tuebingen
72076
Germany

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

Rate of HER2 positive CTCs with each method

Secondary outcome measures

Concordance between the two methods in (HER2 positive) CTC detection

Overall trial start date

01/12/2007

Overall trial end date

01/04/2009

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20859679
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21745383

Publication citations

  1. Results

    Fehm T, Müller V, Aktas B, Janni W, Schneeweiss A, Stickeler E, Lattrich C, Löhberg CR, Solomayer E, Rack B, Riethdorf S, Klein C, Schindlbeck C, Brocker K, Kasimir-Bauer S, Wallwiener D, Pantel K, HER2 status of circulating tumor cells in patients with metastatic breast cancer: a prospective, multicenter trial., Breast Cancer Res. Treat., 2010, 124, 2, 403-412, doi: 10.1007/s10549-010-1163-x.

  2. Results

    Müller V, Riethdorf S, Rack B, Janni W, Fasching PA, Solomayer E, Aktas B, Kasimir-Bauer S, Zeitz J, Pantel K, Fehm T, , Prospective evaluation of serum tissue inhibitor of metalloproteinase 1 and carbonic anhydrase IX in correlation to circulating tumor cells in patients with metastatic breast cancer., Breast Cancer Res., 2011, 13, 4, R71, doi: 10.1186/bcr2916.

Additional files

Editorial Notes