Tumor Bank for Tissue Samples

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Univ.Prof.Dr. Robert Zeillinger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01789229
First received: February 7, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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".


Condition Intervention
Ovarian Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Neoplasms of the Female Genitalia
Lung Neoplasms
Endocrine Gland Neoplasms
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

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Establishment of a Tissue Sample Bank in the Field of Gynaecological Oncology

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls. [ Time Frame: 14 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Universal tumor bank


Estimated Enrollment: 10000
Study Start Date: September 2003
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Malignant tumors
Patients who have one of the Neoplasms stated above under "conditions".
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.

Other: 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.
Other: Collecting urine samples
Patient is asked to give a urine sample. Urine is collected in urine beaker.
Other: Collecting saliva sample
Saliva sample is collected by spatula from the mouth cavity of the patient.
Other: Collecting sputum
Patient is asked to produce sputum into a 50ml lab tube.
Other: Collecting stool samples
Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient.
Other: Lavage/Irrigation
Irrigation liquid is collected during routine therapeutic or diagnostic procedure, e.g. lavage of the uterine cavity during routine saline contrast hysterosonography of women scheduled for surgery.
Benign controls
Patients with a benign tumor or an inflammatory disease - to be matched by age.
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.

Other: 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.
Other: Collecting urine samples
Patient is asked to give a urine sample. Urine is collected in urine beaker.
Other: Collecting saliva sample
Saliva sample is collected by spatula from the mouth cavity of the patient.
Other: Collecting sputum
Patient is asked to produce sputum into a 50ml lab tube.
Other: Collecting stool samples
Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient.
Other: Lavage/Irrigation
Irrigation liquid is collected during routine therapeutic or diagnostic procedure, e.g. lavage of the uterine cavity during routine saline contrast hysterosonography of women scheduled for surgery.
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
Patient is asked to give a urine sample. Urine is collected in urine beaker.
Other: Collecting saliva sample
Saliva sample is collected by spatula from the mouth cavity of the patient.
Other: Collecting sputum
Patient is asked to produce sputum into a 50ml lab tube.
Other: Collecting stool samples
Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient.
Other: Lavage/Irrigation
Irrigation liquid is collected during routine therapeutic or diagnostic procedure, e.g. lavage of the uterine cavity during routine saline contrast hysterosonography of women scheduled for surgery.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789229

Contacts
Contact: Robert Zeillinger, Prof.Dr. +43140400 ext 7831 robert.zeillinger@meduniwien.ac.at
Contact: Nina M Pecha +4340400 ext 2784 nina.pecha@meduniwien.ac.at

Locations
Belgium
University Hospitals Leuven - Department of Obstetrics and Gynaecology Recruiting
Leuven, Belgium, 3000
Contact: Ignace Vergote, Prof.Dr.    +32/1634 ext 4208    ignace.vergote@uzleuven.be   
Contact: Joke de Roover    +32 16 34 ext 74 19    joke.deroover@uz.kuleuven.ac.be   
Germany
Charité University - Campus Virchow Chlinic Recruiting
Berlin, Germany, 13353
Contact: Jalid Sehouli, Prof.Dr.       Jalid.Sehouli@charite.de   
Contact: Ioana Braicu, Dr.    +49 30 450 564 ext 002    ioana@braicu.de   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Robert Zeillinger, Prof.Dr. Medical University of Vienna, Dptm. of Obstetrics & Gynaecology
  More Information

Additional Information:
Publications:

Responsible Party: Univ.Prof.Dr. Robert Zeillinger, Univ.Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01789229     History of Changes
Other Study ID Numbers: EK 260/2003
Study First Received: February 7, 2013
Last Updated: November 14, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Breast cancer
Ovarian cancer
NSCLC (non small cell lung cancer) & SCLC (small cell lung cancer)
Endometrium carcinoma
Cervix carcinoma,
Mamma carcinoma,
Prostata carcinoma
Colon carcinoma
Rectal carcinoma
Bronchus carcinoma
Prostate carcinoma

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Breast Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Breast Diseases
Skin Diseases
Respiratory Tract Diseases
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 16, 2014