|
Introduction
The AdnaTest will be employed by oncologists
who diagnose cancer and subsequently have to initiate an adequate treatment.
It will help to make a prognosis which might result in a decision when
to start treatment and will provide a predictive value supporting the
decision how to treat. The following
will give a short review about AdnaGen´s ongoing trials.
Clinical trials should validate:
- sensitivity and specificity of the
AdnaTests in detection of circulating tumor cells in blood of cancer
patients
- technical feasibility of the AdnaTests
in the clinical routine laboratory
- advantages of the AdnaTests over
standard diagnostics in earlier detection of tumor recurrence and of
metastases
- value of the AdnaTests as new tools
for decision guidance in cancer therapy
Validation of AdnaTest BreastCancer
BR-01-2004
"Detection of circulating tumour
cells in breast cancer: Performance evaluation study of the CE-marked
in vitro diagnostic medical device AdnaTest BreastCancer"
1. Aims
This study is performed to determine
- the prognostic value of the AdnaTest BreastCancer by analyzing breast
cancer patients over a period of three years.
- to evaluate efficacy of neoadjuvant therapy by analyzing breast cancer
patients prior and after therapy administration.
2. Study Design
Study Design BR-01-2004
Non-randomised, open, multicenter study
3. Cooperating Centers
To date patients are recruited one center:
University of Tübingen, Germany, Gynecological Hospital - Prof.
Dr. E.-F. Solomayer, Prof. Wallwiener
Recruitment and data collection are completed.
Data analysis is in progress.
BR-01-2005
"Determination of HER2-antigen
in serum of initially HER2-negative metastasized breast cancer patients"
(With consideration of the HER2 mRNA expression of circulating
tumor cells.)
1. Aim
This pilot type study is performed to determine the prognostic value
of the AdnaTest BreastCancer in CTC as non-invasive diagnostic to predict
clinical prognosis in advanced breast cancer and in addition to provide
a decision guidance for therapy administration with Herceptin.
2. Features
Patients are recruited in a single center. Inclusion criteria are advanced
breast cancer (M1) with initially HER2 negative or HER2 unknown primary
tumor. Patient data are processed as follows: not regulated (ICH-GCP),
non-randomised, open labeled and prospective. HER2
mRNA expression in circulating tumor cells is analyzed by the AdnaTest
BreastCancer.
3. Cooperating Center
University of Tübingen, Germany, Gynecological Hospital - Prof.
Dr. E.-F. Solomayer, Prof. Dr. T. Fehm
Recruitment and data collection are completed.
Results are published.
Determination
of HER2 status using both serum HER2 levels and circulating tumor cells
in patients with recurrent breast cancer
whose primary tumor was HER2 negative or of unknown HER2 status
BR-01-2007
"Detection of circulating tumor
cells as a predictive factor in therapy monitoring"
Molecular
profiling and predictive value of circulating tumor cells in patients
with metastatic breast cancer: an option for monitoring response to
breast cancer related therapies
BR-02-2007
"EMT and stem cell characteristics
of circulating tumor cells"
Identification
of a stem cell marker and markers involved in epithelial-mesenchymal
transition on circulating tumor cells in patients with metastatic breast
cancer
Validation of AdnaTest ColonCancer
CO-03-2004
"Detection of circulating tumor
cells from metastasized colorectal cancer patients"
1. Aim
This pilot type study is performed to determine the predictive value of
the AdnaTest ColonCancer in evaluating efficacy of cancer therapy. Colon
cancer patients with advanced disease and metastasizing tumors were chosen
on the assumption to have elevated numbers of circulating tumor cells
in their peripheral blood. Successful therapy should lead to decreased
numbers of circulating tumor cells yielding a negative AdnaTest result.
Diseases discussed as possible precanceroses are included as well, i.e.
patients with inflammatory gastrointestinal diseases like Crohn's disease
or ulcerative colitis, to evaluate the specificity of the AdnaTest ColonCancer.
2. Features
Patients are recruited in a single center. Inclusion criteria are advanced
colorectal cancer (M1) and patients suffering from Crohn's disease or
ulcerative colitis. Patient data are processed as follows: not regulated
(ICH-GCP), non-randomised, open labeled and prospective.
3. Cooperating Center
Medical School Hannover, Germany, Dept.
Gastroenterology and Hepatology - Prof. Dr. T. Greten
Collection of blood samples since 10/2004. Recruitment
and data analysis are completed. Results will be published.
CO-01-2005
"Characterization of EGFR expression
on circulating tumor cells in the peripheral blood of colorectal cancer
patients"
1. Aim
EGFR is a target for several new drugs like therapeutic antibodies and
low MW signal transduction inhibitors which are promising tools in optimized
and individualized cancer therapy.
This pilot type study is performed to characterize EGFR on circulating
tumor cells to provide a new diagnostic as guidance in therapy decision
and drug application. In addition this study will confirm the relevance
of circulating tumor cells as indicator of the situation of the patient
which might reflect much better the patient´s status than immunohistological
analysis of the formerly resected primary tumor.
2. Features
Patients are recruited in a single center. Inclusion criteria are advanced
colorectal cancer (M1), with surgically resectable liver metastases.
Patient data are processed as follows: not regulated (ICH-GCP), non-randomised,
open labeled and prospective.
3. Cooperating Center
Medical School Hannover, Germany, Dept.
Gastroenterology and Hepatology - Prof. Dr. T. Greten
Recruitment and data analysis are completed. Results will be published.
Tumour-associated
transcripts and EGFR deletion variants in colorectal cancer in primary
tumour, metastases and circulating tumour cells
|
