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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01789229
Other study ID # EK 260/2003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 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
Health authority
Study type Observational

Clinical Trial 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".


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).


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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tumor tissue collection
Tissue sample is collected during therapeutic intervention by a medical doctor/surgeon. Frozen tissue sections are first transferred to Dept.of Pathology. Pathologist samples required tissue to obtain enough evidence for analysis/diagnosis. Rest tumor material with or without malignant cells is tranferred to the lab for Molecular Oncology of Prof.Zeillinger.
Sampling of ascites and pleural effusion
Samples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care.
Collecting urine samples
Patient is asked to give a urine sample. Urine is collected in urine beaker.
Collecting saliva sample
Saliva sample is collected by spatula from the mouth cavity of the patient.
Collecting sputum
Patient is asked to produce sputum into a 50ml lab tube.
Collecting stool samples
Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient.
Lavage/Irrigation
Irrigation liquid is collected during routine therapeutic or diagnostic procedure, e.g. lavage of the uterine cavity and fallopian tubes of women scheduled for surgery.

Locations

Country Name City State
Austria Medical University Vienna, Dptm. of Obstetrics & Gynaecology Vienna
Belgium University Hospitals Leuven - Department of Obstetrics and Gynaecology Leuven
Germany Charité University - Campus Virchow Chlinic Berlin

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

References & Publications (5)

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 — View 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 prognosti — View 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 — View 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):946-5 — View 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;1 — 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
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