Ovarian NeoplasmsNCT01763125
Establishment of a Tumor Bank for Blood Samples
An observational study of Ovarian Neoplasms and Breast Neoplasms, run by Medical University of Vienna at 6 sites in 4 countries.
Trial summary
Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood 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?
- Blood collection
- How many people
- 10,000 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Nov 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
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Germany3 sites, 1 recruiting
- Recruiting
Charité University - Campus Virchow Chlinic
Berlin, 13353
Jalid Sehouli, Prof.Dr., Jalid.Sehouli@charite.de
Ioana Braicu, Dr., +49 30 450 564 ext. 002, ioana@braicu.de
- Completed
University Medical Center Freiburg
Freiburg im Breisgau, 79106
- Completed
University Clinic of Ruhr University Bochum
Herne, 44626
Belgium1 site
- Completed
University Hospitals Leuven - Department of Obstetrics and Gynaecology
Leuven, 3000
Italy1 site
- Withdrawn
European Institute of Oncology, Division of Gynecologic Oncology, Unit of Preventive Gynecology
Milan, 20100
About this study
Official title: Establishment of a Blood Sample Bank in the Field of Gynaecological Oncology.
Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood 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 tumor bank.
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 tissue bank - see EK 260/2003) 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
- Blood collection
- Keywords
- circulating tumor cells, CTC, tumor marker
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Endocrine Gland Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood sample is collected during routine blood collection by a medical doctor. No more than 60ml (max.) at one timepoint.
| Study group | Role | What they receive |
|---|---|---|
| Malignant tumors | Patients who have one of the Neoplasms stated above under "conditions". Blood samples will be taken. Receives: Other: Blood collection | |
| Benign controls | Patients with a benign tumor or an inflammatory disease - to be matched by age and affected organ with a patient with a malignant disease.
Blood samples will be taken. Receives: Other: Blood collection | |
| Healthy controls | People/patients who have no known disease at time of blood sampling or are admitted to the hospital for minor interventions and have no inflammatory disease.
Blood samples will be taken. Receives: Other: Blood collection |
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 posted8 Jan 2013 (estimated)
- Study startNov 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 (6)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 Vienna, Dept. of Obstetrics & Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763125
- Sponsor's protocol ID
- EK 366/2003
- Status last verified
- Mar 2023
- First submitted
- 4 Jan 2013
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Hefler LA, Concin N, Hofstetter G, Marth C, Mustea A, Sehouli J, Zeillinger R, Leipold H, Lass H, Grimm C, Tempfer CB, Reinthaller A. Serum C-reactive protein as independent prognostic variable in patients with ovarian cancer. Clin Cancer Res. 2008 Feb 1;14(3):710-4. doi: 10.1158/1078-0432.CCR-07-1044.
PubMed 18245530Konigsberg R, Gneist M, Jahn-Kuch D, Pfeiler G, Hager G, Hudec M, Dittrich C, Zeillinger R. Circulating tumor cells in metastatic colorectal cancer: efficacy and feasibility of different enrichment methods. Cancer Lett. 2010 Jul 1;293(1):117-23. doi: 10.1016/j.canlet.2010.01.003. Epub 2010 Feb 18.
PubMed 20167419Obermayr E, Sanchez-Cabo F, Tea MK, Singer CF, Krainer M, Fischer MB, Sehouli J, Reinthaller A, Horvat R, Heinze G, Tong D, Zeillinger R. Assessment of a six gene panel for the molecular detection of circulating tumor cells in the blood of female cancer patients. BMC Cancer. 2010 Dec 3;10:666. doi: 10.1186/1471-2407-10-666.
PubMed 21129172Konigsberg R, Obermayr E, Bises G, Pfeiler G, Gneist M, Wrba F, de Santis M, Zeillinger R, Hudec M, Dittrich C. Detection of EpCAM positive and negative circulating tumor cells in metastatic breast cancer patients. Acta Oncol. 2011 Jun;50(5):700-10. doi: 10.3109/0284186X.2010.549151. Epub 2011 Jan 24.
PubMed 21261508Obermayr E, Castillo-Tong DC, Pils D, Speiser P, Braicu I, Van Gorp T, Mahner S, Sehouli J, Vergote I, Zeillinger R. Molecular characterization of circulating tumor cells in patients with ovarian cancer improves their prognostic significance -- a study of the OVCAD consortium. Gynecol Oncol. 2013 Jan;128(1):15-21. doi: 10.1016/j.ygyno.2012.09.021. Epub 2012 Sep 24.
PubMed 23017820Hasenburg A, Eichkorn D, Vosshagen F, Obermayr E, Geroldinger A, Zeillinger R, Bossart M. Biomarker-based early detection of epithelial ovarian cancer based on a five-protein signature in patient's plasma - a prospective trial. BMC Cancer. 2021 Sep 16;21(1):1037. doi: 10.1186/s12885-021-08682-y.
PubMed 34530759
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 Blood Sample Bank in the Field of Gynaecological Oncology.
- ClinicalTrials.gov ID
- NCT01763125
- Acronym / sponsor ID
- EK 366/2003
- Conditions
- Ovarian Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Neoplasms of the Female Genitalia, Lung Neoplasms, Endocrine Gland Neoplasms
- Keywords
- circulating tumor cells, CTC, tumor marker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 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 blood samples of tumor patients and healthy people as controls. The blood 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 tumor bank.
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 tissue bank - see EK 260/2003) 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: Blood collectionPatients who have one of the Neoplasms stated above under "conditions". Blood samples will be taken. |
| Benign controls | – | Other: Blood collectionPatients with a benign tumor or an inflammatory disease - to be matched by age and affected organ with a patient with a malignant disease. Blood samples will be taken. |
| Healthy controls | – | Other: Blood collectionPeople/patients who have no known disease at time of blood sampling or are admitted to the hospital for minor interventions and have no inflammatory disease. Blood samples will be taken. |
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 (4 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 |
|---|---|---|
| Blood collectionBlood sample is collected during routine blood collection by a medical doctor. No more than 60ml (max.) at one timepoint. | 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 18245530Hefler LA, Concin N, Hofstetter G, Marth C, Mustea A, Sehouli J, Zeillinger R, Leipold H, Lass H, Grimm C, Tempfer CB, Reinthaller A. Serum C-reactive protein as independent prognostic variable in patients with ovarian cancer. Clin Cancer Res. 2008 Feb 1;14(3):710-4. doi: 10.1158/1078-0432.CCR-07-1044.
- Results publication: PubMed 20167419Konigsberg R, Gneist M, Jahn-Kuch D, Pfeiler G, Hager G, Hudec M, Dittrich C, Zeillinger R. Circulating tumor cells in metastatic colorectal cancer: efficacy and feasibility of different enrichment methods. Cancer Lett. 2010 Jul 1;293(1):117-23. doi: 10.1016/j.canlet.2010.01.003. Epub 2010 Feb 18.
- Results publication: PubMed 21129172Obermayr E, Sanchez-Cabo F, Tea MK, Singer CF, Krainer M, Fischer MB, Sehouli J, Reinthaller A, Horvat R, Heinze G, Tong D, Zeillinger R. Assessment of a six gene panel for the molecular detection of circulating tumor cells in the blood of female cancer patients. BMC Cancer. 2010 Dec 3;10:666. doi: 10.1186/1471-2407-10-666.
- Results publication: PubMed 21261508Konigsberg R, Obermayr E, Bises G, Pfeiler G, Gneist M, Wrba F, de Santis M, Zeillinger R, Hudec M, Dittrich C. Detection of EpCAM positive and negative circulating tumor cells in metastatic breast cancer patients. Acta Oncol. 2011 Jun;50(5):700-10. doi: 10.3109/0284186X.2010.549151. Epub 2011 Jan 24.
- Results publication: PubMed 23017820Obermayr E, Castillo-Tong DC, Pils D, Speiser P, Braicu I, Van Gorp T, Mahner S, Sehouli J, Vergote I, Zeillinger R. Molecular characterization of circulating tumor cells in patients with ovarian cancer improves their prognostic significance -- a study of the OVCAD consortium. Gynecol Oncol. 2013 Jan;128(1):15-21. doi: 10.1016/j.ygyno.2012.09.021. Epub 2012 Sep 24.
- Derived from this study: PubMed 34530759Hasenburg A, Eichkorn D, Vosshagen F, Obermayr E, Geroldinger A, Zeillinger R, Bossart M. Biomarker-based early detection of epithelial ovarian cancer based on a five-protein signature in patient's plasma - a prospective trial. BMC Cancer. 2021 Sep 16;21(1):1037. doi: 10.1186/s12885-021-08682-y.
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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 Vienna, Dept. of Obstetrics & Gynaecology
6 sites in 4 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 6 sites in 4 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 4 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 6 sites in Germany, Austria, Belgium, Italy. 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 NCT01763125, which also lists 6 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.