Establishment of a Tumor Bank for Tissue Samples

Breast Neoplasms Clinical Trial

Official title:

Establishment of a Tissue Sample Bank in the Field of Gynaecological Oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01789229
• Other study ID #: EK 260/2003
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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