- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763125
Establishment of a Tumor Bank for Blood Samples
Establishment of a Blood Sample Bank in the Field of Gynaecological Oncology.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent progress in diagnosis and therapy of cancer diseases can be ascribed mainly to translational research. The relevance of "translational oncology" will only increase in the future -"From bench to bedside" - the swift implementation of new science research results in clinical studies in order to expedite progress in clinical cancer therapy for the benefit of the patient.
Its almost a matter of course in the medical science today to collect biological samples together with clinical information thereby creating the foundation for future excellent fundamental research.
The aim of this tumor bank is to consist of biological samples (together with a tissue bank - see EK 260/2003) and isolates of tumor patients and healthy people as controls. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank. The content of the tumor bank can provide essential material for current and future research (e.g. analyses of prognostic or predictive tumor markers; genetically analysis (polymorphism, mutation, hypermethylation; verification and characterisation of disseminated tumor cells).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Robert Zeillinger, Prof. Dr.
- Phone Number: 78310 +43140400
- Email: robert.zeillinger@meduniwien.ac.at
Study Contact Backup
- Name: Eva Obermayr, PhD
- Phone Number: 78270 +43140400
- Email: eva.obermayr@muv.ac.at
Study Locations
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Innsbruck, Austria, 6020
- Completed
- Innsbruck Medical University
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-
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Leuven, Belgium, 3000
- Completed
- University Hospitals Leuven - Department of Obstetrics and Gynaecology
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Berlin, Germany, 13353
- Recruiting
- Charité University - Campus Virchow Chlinic
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Contact:
- Jalid Sehouli, Prof.Dr.
- Email: Jalid.Sehouli@charite.de
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Contact:
- Ioana Braicu, Dr.
- Phone Number: 002 +49 30 450 564
- Email: ioana@braicu.de
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Freiburg, Germany, 79106
- Completed
- University Medical Center Freiburg
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Herne, Germany, 44626
- Completed
- University Clinic of Ruhr University Bochum
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Milan, Italy, 20100
- Withdrawn
- European Institute of Oncology, Division of Gynecologic Oncology, Unit of Preventive Gynecology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Male and female patients/people.
- Minimum age 18 years
- Characteristics: Recruited at the Medical University Vienna or at one of the facilities cooperating with the Vienna Med. University
Description
Inclusion Criteria:
- Male/Female
- Age 18 to 90 years max.
- Just one current known malignant disease or
- Just one current inflammatory disease
Exclusion Criteria:
- Inflammatory disease and malignant disease
- multiple malignancies
- multiple diseases
- underage
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Malignant tumors
Patients who have one of the Neoplasms stated above under "conditions".
Blood samples will be taken.
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Blood sample is collected during routine blood collection by a medical doctor.
No more than 60ml (max.) at one timepoint.
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Benign controls
Patients with a benign tumor or an inflammatory disease - to be matched by age and affected organ with a patient with a malignant disease. Blood samples will be taken. |
Blood sample is collected during routine blood collection by a medical doctor.
No more than 60ml (max.) at one timepoint.
|
|
Healthy controls
People/patients who have no known disease at time of blood sampling or are admitted to the hospital for minor interventions and have no inflammatory disease. Blood samples will be taken. |
Blood sample is collected during routine blood collection by a medical doctor.
No more than 60ml (max.) at one timepoint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.
Time Frame: 14 years
|
14 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Zeillinger, Prof.Dr., Medical University Vienna, Dept. of Obstetrics & Gynaecology
Publications and helpful links
General Publications
- Hefler LA, Concin N, Hofstetter G, Marth C, Mustea A, Sehouli J, Zeillinger R, Leipold H, Lass H, Grimm C, Tempfer CB, Reinthaller A. Serum C-reactive protein as independent prognostic variable in patients with ovarian cancer. Clin Cancer Res. 2008 Feb 1;14(3):710-4. doi: 10.1158/1078-0432.CCR-07-1044.
- Konigsberg R, Gneist M, Jahn-Kuch D, Pfeiler G, Hager G, Hudec M, Dittrich C, Zeillinger R. Circulating tumor cells in metastatic colorectal cancer: efficacy and feasibility of different enrichment methods. Cancer Lett. 2010 Jul 1;293(1):117-23. doi: 10.1016/j.canlet.2010.01.003. Epub 2010 Feb 18.
- Obermayr E, Sanchez-Cabo F, Tea MK, Singer CF, Krainer M, Fischer MB, Sehouli J, Reinthaller A, Horvat R, Heinze G, Tong D, Zeillinger R. Assessment of a six gene panel for the molecular detection of circulating tumor cells in the blood of female cancer patients. BMC Cancer. 2010 Dec 3;10:666. doi: 10.1186/1471-2407-10-666.
- Konigsberg R, Obermayr E, Bises G, Pfeiler G, Gneist M, Wrba F, de Santis M, Zeillinger R, Hudec M, Dittrich C. Detection of EpCAM positive and negative circulating tumor cells in metastatic breast cancer patients. Acta Oncol. 2011 Jun;50(5):700-10. doi: 10.3109/0284186X.2010.549151. Epub 2011 Jan 24.
- Obermayr E, Castillo-Tong DC, Pils D, Speiser P, Braicu I, Van Gorp T, Mahner S, Sehouli J, Vergote I, Zeillinger R. Molecular characterization of circulating tumor cells in patients with ovarian cancer improves their prognostic significance -- a study of the OVCAD consortium. Gynecol Oncol. 2013 Jan;128(1):15-21. doi: 10.1016/j.ygyno.2012.09.021. Epub 2012 Sep 24.
- Hasenburg A, Eichkorn D, Vosshagen F, Obermayr E, Geroldinger A, Zeillinger R, Bossart M. Biomarker-based early detection of epithelial ovarian cancer based on a five-protein signature in patient's plasma - a prospective trial. BMC Cancer. 2021 Sep 16;21(1):1037. doi: 10.1186/s12885-021-08682-y.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms
- Breast Neoplasms
- Lung Neoplasms
- Colorectal Neoplasms
- Ovarian Neoplasms
- Endocrine Gland Neoplasms
Other Study ID Numbers
- EK 366/2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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