Establishment of a Tumor Bank for Tissue Samples

NCT01789229 | Recruiting DMC

• 1 other identifier: EK 260/2003
• Study Type: observational
• Target: 10,000
• Locations: 3 countries
• Sites: 3

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".

Conditions

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

Keywords

biobank; fresh-frozen tissue

Outcome Measures

Primary Outcomes (1)

• Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.

  14 years

Study Arms (3)

Malignant tumors

Patients who have one of the Neoplasms stated above under "conditions".

Other: Tumor tissue collection; Other: Sampling of ascites and pleural effusion; Other: Collecting urine samples; Other: Collecting saliva sample; Other: Collecting sputum; Other: Collecting stool samples; Other: Lavage/Irrigation

Benign controls

Patients with a benign tumor or an inflammatory disease - to be matched by age.

Other: Tumor tissue collection; Other: Sampling of ascites and pleural effusion; Other: Collecting urine samples; Other: Collecting saliva sample; Other: Collecting sputum; Other: Collecting stool samples; Other: Lavage/Irrigation

Healthy controls

People/patients who have no known disease at time of sampling or are admitted to the hospital for minor interventions and have no inflammatory disease.

Other: Collecting urine samples; Other: Collecting saliva sample; Other: Collecting sputum; Other: Collecting stool samples; Other: Lavage/Irrigation

Interventions

Tumor tissue collection OTHER

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.

Benign controls; Malignant tumors

Sampling of ascites and pleural effusion OTHER

Samples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care.

Benign controls; Malignant tumors

Collecting urine samples OTHER

Patient is asked to give a urine sample. Urine is collected in urine beaker.

Benign controls; Healthy controls; Malignant tumors

Collecting saliva sample OTHER

Saliva sample is collected by spatula from the mouth cavity of the patient.

Benign controls; Healthy controls; Malignant tumors

Collecting sputum OTHER

Patient is asked to produce sputum into a 50ml lab tube.

Benign controls; Healthy controls; Malignant tumors

Collecting stool samples OTHER

Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient.

Benign controls; Healthy controls; Malignant tumors

Lavage/Irrigation OTHER

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.

Benign controls; Healthy controls; Malignant tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male/Female
• Age 18 to 90 years max.
• Just one current known malignant disease or just one current inflammatory disease

You may not qualify if:

• Inflammatory disease and malignant disease
• multiple malignancies
• multiple diseases
• underage

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (3)

Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Vienna, 1090, Austria

RECRUITING

University Hospitals Leuven - Department of Obstetrics and Gynaecology

Leuven, 3000, Belgium

COMPLETED

Charité University - Campus Virchow Chlinic

Berlin, 13353, Germany

ACTIVE NOT RECRUITING

Related Publications (5)

• 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.

  PMID: 20101229 RESULT

• 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.

  PMID: 21159173 RESULT

• 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.

  PMID: 21376376 RESULT

• 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.

  PMID: 22009029 RESULT

• 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.

  PMID: 23096450 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Universal tumor bank

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Endocrine Gland Neoplasms

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Robert Zeillinger, Prof.Dr.

  Medical University of Vienna, Dptm. of Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Zeillinger, Prof.Dr.

CONTACT

+43140400; robert.zeillinger@meduniwien.ac.at

Eva Obermayr, PhD

CONTACT

+4340400; eva.obermayr@muv.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Prof. Dr.

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 12, 2013
• Study Start: September 1, 2003
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

AU (1); BE (1); DE (1)