Clinical trial NCT01789229: Establishment of a Tumor Bank for Tissue Samples
Official title: Establishment of a Tissue 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: biobank
fresh-frozen tissue
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-02-12
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 tissue samples of tumor patients (benign and malign tumors) and healthy people as controls. The tissue 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 tissue tumor bank.

This tumor bank for tissue samples, together with our tumorbank for blood samples (NCT01763125) combined constitute the entity "Tumorbank".

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 blood bank - see NCT01763125) 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: Vienna
country: Austria
facility: Medical University Vienna, Dptm. of Obstetrics & Gynaecology
city: Leuven
country: Belgium
facility: University Hospitals Leuven - Department of Obstetrics and Gynaecology
city: Berlin
country: Germany
facility: Charité University - Campus Virchow Chlinic
Study officials:
affiliation: Medical University of Vienna, Dptm. of Obstetrics & Gynaecology
name: Robert Zeillinger, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofstetter G, Berger A, Fiegl H, Slade N, Zoric A, Holzer B, Schuster E, Mobus VJ, Reimer D, Daxenbichler G, Marth C, Zeimet AG, Concin N, Zeillinger R. Alternative splicing of p53 and p73: the novel p53 splice variant p53delta is an independent prognostic marker in ovarian cancer. Oncogene. 2010 Apr 1;29(13):1997-2004. doi: 10.1038/onc.2009.482. Epub 2010 Jan 18.
citation: Tong D, Heinze G, Pils D, Wolf A, Singer CF, Concin N, Hofstetter G, Schiebel I, Rudas M, Zeillinger R. Gene expression of PMP22 is an independent prognostic factor for disease-free and overall survival in breast cancer patients. BMC Cancer. 2010 Dec 15;10:682. doi: 10.1186/1471-2407-10-682.
citation: Grimm C, Watrowski R, Baumuhlner K, Natter C, Tong D, Wolf A, Zeillinger R, Leodolter S, Reinthaller A, Hefler L. Genetic variations of interleukin-1 and -6 genes and risk of cervical intraepithelial neoplasia. Gynecol Oncol. 2011 Jun 1;121(3):537-41. doi: 10.1016/j.ygyno.2011.02.019. Epub 2011 Mar 3.
citation: Hofstetter G, Berger A, Schuster E, Wolf A, Hager G, Vergote I, Cadron I, Sehouli J, Braicu EI, Mahner S, Speiser P, Marth C, Zeimet AG, Ulmer H, Zeillinger R, Concin N. Delta133p53 is an independent prognostic marker in p53 mutant advanced serous ovarian cancer. Br J Cancer. 2011 Nov 8;105(10):1593-9. doi: 10.1038/bjc.2011.433. Epub 2011 Oct 18.
citation: Pils D, Horak P, Vanhara P, Anees M, Petz M, Alfanz A, Gugerell A, Wittinger M, Gleiss A, Auner V, Tong D, Zeillinger R, Braicu EI, Sehouli J, Krainer M. Methylation status of TUSC3 is a prognostic factor in ovarian cancer. Cancer. 2013 Mar 1;119(5):946-54. doi: 10.1002/cncr.27850. Epub 2012 Oct 23.