- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01789229
Establishment of a Tumor Bank for Tissue Samples
Establishment of a Tissue Sample Bank in the Field of Gynaecological Oncology
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".
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Robert Zeillinger, Prof.Dr.
- Phone Number: 78310 +43140400
- Email: robert.zeillinger@meduniwien.ac.at
Study Contact Backup
- Name: Eva Obermayr, PhD
- Phone Number: 78270 +4340400
- Email: eva.obermayr@muv.ac.at
Study Locations
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Vienna, Austria, 1090
- Recruiting
- Medical University Vienna, Dptm. of Obstetrics & Gynaecology
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Contact:
- Christoph Grimm, assoc. Prof., MD
- Email: christoph.grimm@muv.ac.at
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Contact:
- Stephan Polterauer, assoc. Prof., MD
- Email: stephan.polterauer@muv.ac.at
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Leuven, Belgium, 3000
- Completed
- University Hospitals Leuven - Department of Obstetrics and Gynaecology
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Berlin, Germany, 13353
- Active, not recruiting
- Charité University - Campus Virchow Chlinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Malignant tumors
Patients who have one of the Neoplasms stated above under "conditions".
|
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.
Samples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care.
Patient is asked to give a urine sample.
Urine is collected in urine beaker.
Saliva sample is collected by spatula from the mouth cavity of the patient.
Patient is asked to produce sputum into a 50ml lab tube.
Stool samples are collected prior to bowel preparation for colonoscopy.
Device for sampling is provided to the patient.
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.
|
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.
Samples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care.
Patient is asked to give a urine sample.
Urine is collected in urine beaker.
Saliva sample is collected by spatula from the mouth cavity of the patient.
Patient is asked to produce sputum into a 50ml lab tube.
Stool samples are collected prior to bowel preparation for colonoscopy.
Device for sampling is provided to the patient.
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.
|
Patient is asked to give a urine sample.
Urine is collected in urine beaker.
Saliva sample is collected by spatula from the mouth cavity of the patient.
Patient is asked to produce sputum into a 50ml lab tube.
Stool samples are collected prior to bowel preparation for colonoscopy.
Device for sampling is provided to the patient.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.
Time Frame: 14 years
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14 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Zeillinger, Prof.Dr., Medical University of Vienna, Dptm. of Obstetrics & Gynaecology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms
- Breast Neoplasms
- Lung Neoplasms
- Colorectal Neoplasms
- Ovarian Neoplasms
- Endocrine Gland Neoplasms
Other Study ID Numbers
- EK 260/2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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