Establishment of a Tumor Bank for Blood Samples

Breast Neoplasms Clinical Trial

Official title:

Establishment of a Blood Sample Bank in the Field of Gynaecological Oncology.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01763125
• Other study ID #: EK 366/2003
• Status: Recruiting
• Start date: November 2003
• Est. completion date: December 2026

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: Robert Zeillinger, Prof. Dr.
• Phone: +43140400
• Email: robert.zeillinger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood samples will be collected systematically together with the corresponding clinical data. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Endocrine Gland Neoplasms
• Lung Neoplasms
• Neoplasms
• Neoplasms of the Female Genitalia
• Ovarian Neoplasms

Intervention

Other:
• Blood collection
Blood sample is collected during routine blood collection by a medical doctor. No more than 60ml (max.) at one timepoint.

Locations

Country	Name	City	State
Austria	Innsbruck Medical University	Innsbruck
Belgium	University Hospitals Leuven - Department of Obstetrics and Gynaecology	Leuven
Germany	Charité University - Campus Virchow Chlinic	Berlin
Germany	University Medical Center Freiburg	Freiburg
Germany	University Clinic of Ruhr University Bochum	Herne
Italy	European Institute of Oncology, Division of Gynecologic Oncology, Unit of Preventive Gynecology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy, 

References & Publications (5)

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; — View Citation

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: 10.1 — View Citation

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: — View Citation

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 — View Citation

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 p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.		14 years