Clinical trial NCT01763125: Establishment of a Tumor Bank for Blood Samples
Official title: Establishment of a Blood Sample Bank in the Field of Gynaecological Oncology.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Neoplasms of the Female Genitalia
Lung Neoplasms
Endocrine Gland Neoplasms
Keywords: circulating tumor cells
CTC
tumor marker
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.
timeFrame: 14 years
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
city: Leuven
country: Belgium
facility: University Hospitals Leuven - Department of Obstetrics and Gynaecology
city: Berlin
country: Germany
facility: Charité University - Campus Virchow Chlinic
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Herne
country: Germany
facility: University Clinic of Ruhr University Bochum
city: Milan
country: Italy
facility: European Institute of Oncology, Division of Gynecologic Oncology, Unit of Preventive Gynecology
Study officials:
affiliation: Medical University Vienna, Dept. of Obstetrics & Gynaecology
name: Robert Zeillinger, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 10.1016/j.canlet.2010.01.003. Epub 2010 Feb 18.
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 patients. BMC Cancer. 2010 Dec 3;10:666. doi: 10.1186/1471-2407-10-666.
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: 10.3109/0284186X.2010.549151. Epub 2011 Jan 24.
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 the OVCAD consortium. Gynecol Oncol. 2013 Jan;128(1):15-21. doi: 10.1016/j.ygyno.2012.09.021. Epub 2012 Sep 24.
citation: 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.