Ovarian NeoplasmsNCT01789229
Establishment of a Tumor Bank for Tissue Samples
An observational study of Ovarian Neoplasms and Breast Neoplasms, run by Medical University of Vienna at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ovarian Neoplasms, Breast Neoplasms, Colorectal Neoplasms
- What is being tested?
- Tumor tissue collection, Sampling of ascites and pleural effusion and Collecting urine samples
- How many people
- 10,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2003to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Male/Female
- Age 18 to 90 years max.
- Just one current known malignant disease or just one current inflammatory disease
Who cannot join
- Inflammatory disease and malignant disease
- multiple malignancies
- multiple diseases
- underage
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Vienna, 1090
Christoph Grimm, assoc. Prof., MD, christoph.grimm@muv.ac.at
Stephan Polterauer, assoc. Prof., MD, stephan.polterauer@muv.ac.at
Belgium1 site
- Completed
University Hospitals Leuven - Department of Obstetrics and Gynaecology
Leuven, 3000
Germany1 site
- Active, not recruiting
Charité University - Campus Virchow Chlinic
Berlin, 13353
About this study
Official title: 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".
Read the 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).
- Conditions
- Ovarian Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Neoplasms of the Female Genitalia, Lung Neoplasms, Endocrine Gland Neoplasms
- Being tested
- Tumor tissue collection, Sampling of ascites and pleural effusion, Collecting urine samples, Collecting saliva sample, Collecting sputum
- Keywords
- biobank, fresh-frozen tissue
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Endocrine Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor tissue collectionOther
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.
Sampling of ascites and pleural effusionOther
Samples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care.
Collecting urine samplesOther
Patient is asked to give a urine sample. Urine is collected in urine beaker.
Collecting saliva sampleOther
Saliva sample is collected by spatula from the mouth cavity of the patient.
Collecting sputumOther
Patient is asked to produce sputum into a 50ml lab tube.
Collecting stool samplesOther
Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient.
Lavage/IrrigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Malignant tumors | Patients who have one of the Neoplasms stated above under "conditions". Receives: 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. Receives: 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. Receives: Other: Collecting urine samples; Other: Collecting saliva sample; Other: Collecting sputum; Other: Collecting stool samples; Other: Lavage/Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startSep 2003
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Zeillinger, Dr.phil., Medical University of Vienna
- Investigators
- Robert Zeillinger, Prof.Dr., Principal investigator, Medical University of Vienna, Dptm. of Obstetrics & Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789229
- Sponsor's protocol ID
- EK 260/2003
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2013
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20101229Tong 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.
PubMed 21159173Grimm 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.
PubMed 21376376Hofstetter 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.
PubMed 22009029Pils 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.
PubMed 23096450
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Tissue Sample Bank in the Field of Gynaecological Oncology
- ClinicalTrials.gov ID
- NCT01789229
- Acronym / sponsor ID
- EK 260/2003
- Conditions
- Ovarian Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Neoplasms of the Female Genitalia, Lung Neoplasms, Endocrine Gland Neoplasms
- Keywords
- biobank, fresh-frozen tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malignant tumors | – | 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/IrrigationPatients who have one of the Neoplasms stated above under "conditions". |
| Benign controls | – | 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/IrrigationPatients with a benign tumor or an inflammatory disease - to be matched by age. |
| Healthy controls | – | Other: Collecting urine samples, Other: Collecting saliva sample, Other: Collecting sputum, Other: Collecting stool samples, Other: Lavage/IrrigationPeople/patients who have no known disease at time of sampling or are admitted to the hospital for minor interventions and have no inflammatory disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Male/Female
- Age 18 to 90 years max.
- Just one current known malignant disease or just one current inflammatory disease
Key exclusion criteria (4 listed)
- Inflammatory disease and malignant disease
- multiple malignancies
- multiple diseases
- underage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor tissue collectionTissue 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 | Benign controls, Malignant tumors |
| Sampling of ascites and pleural effusionSamples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care. | Other | Benign controls, Malignant tumors |
| Collecting urine samplesPatient is asked to give a urine sample. Urine is collected in urine beaker. | Other | Benign controls, Healthy controls, Malignant tumors |
| Collecting saliva sampleSaliva sample is collected by spatula from the mouth cavity of the patient. | Other | Benign controls, Healthy controls, Malignant tumors |
| Collecting sputumPatient is asked to produce sputum into a 50ml lab tube. | Other | Benign controls, Healthy controls, Malignant tumors |
| Collecting stool samplesStool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient. | Other | Benign controls, Healthy controls, Malignant tumors |
| Lavage/IrrigationIrrigation liquid is collected during routine therapeutic or diagnostic procedure, e.g. lavage of the uterine cavity and fallopian tubes of women scheduled for surgery. | Other | Benign controls, Healthy controls, Malignant tumors |
Primary outcome
Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.
Time frame: 14 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Results publication: PubMed 20101229Hofstetter 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.
- Results publication: PubMed 21159173Tong 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.
- Results publication: PubMed 21376376Grimm 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.
- Results publication: PubMed 22009029Hofstetter 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.
- Results publication: PubMed 23096450Pils 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Zeillinger, Prof.Dr. principal investigator
Medical University of Vienna, Dptm. of Obstetrics & Gynaecology
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Breast Neoplasms, run by Medical University of Vienna at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Zeillinger, Prof.Dr. (+43140400 ext. 78310, robert.zeillinger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls. (time frame: 14 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01789229, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.