Establishment of a Tumor Bank for Tissue Samples

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT01789229
Collaborator
(none)
10,000
3
256
3333.3
13

Study Details

Study Description

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".

Condition or Disease Intervention/Treatment Phase
  • 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

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Establishment of a Tissue Sample Bank in the Field of Gynaecological Oncology
Study Start Date :
Sep 1, 2003
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls. [14 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Medical University Vienna, Dptm. of Obstetrics & Gynaecology Vienna Austria 1090
2 University Hospitals Leuven - Department of Obstetrics and Gynaecology Leuven Belgium 3000
3 Charité University - Campus Virchow Chlinic Berlin Germany 13353

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Robert Zeillinger, Prof.Dr., Medical University of Vienna, Dptm. of Obstetrics & Gynaecology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert Zeillinger, Dr.phil., Univ.Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01789229
Other Study ID Numbers:
  • EK 260/2003
First Posted:
Feb 12, 2013
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021
Keywords provided by Robert Zeillinger, Dr.phil., Univ.Prof. Dr., Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2021