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Tumor Bank for Tissue Samples

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Univ.Prof.Dr. Robert Zeillinger, Medical University of Vienna.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789229
First Posted: February 12, 2013
Last Update Posted: September 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Univ.Prof.Dr. Robert Zeillinger, Medical University of Vienna
  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 Univ.Prof.Dr. Robert Zeillinger, 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 ]

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 and fallopian tubes 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 and fallopian tubes 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 and fallopian tubes 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 7, 2013
First Posted: February 12, 2013
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Univ.Prof.Dr. Robert Zeillinger, 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
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Breast Diseases
Skin Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Diseases
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders