Establishment of a Tumor Bank for Blood Samples

NCT01763125 | Recruiting

• 1 other identifier: EK 366/2003
• Study Type: observational
• Target: 10,000
• Locations: 4 countries
• Sites: 6

Brief 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. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank.

Conditions

Ovarian Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Neoplasms of the Female Genitalia; Lung Neoplasms; Endocrine Gland Neoplasms

Keywords

circulating tumor cells; CTC; tumor marker

Outcome Measures

Primary Outcomes (1)

• Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.

  14 years

Study Arms (3)

Malignant tumors

Patients who have one of the Neoplasms stated above under "conditions". Blood samples will be taken.

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.

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.

Other: Blood collection

Interventions

Blood collection OTHER

Blood sample is collected during routine blood collection by a medical doctor. No more than 60ml (max.) at one timepoint.

Benign controls; Healthy controls; Malignant tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male/Female
• Age 18 to 90 years max.
• Just one current known malignant disease or
• Just one current inflammatory disease

You may not qualify if:

• Inflammatory disease and malignant disease
• multiple malignancies
• multiple diseases
• underage

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (6)

Innsbruck Medical University

Innsbruck, 6020, Austria

COMPLETED

University Hospitals Leuven - Department of Obstetrics and Gynaecology

Leuven, 3000, Belgium

COMPLETED

Charité University - Campus Virchow Chlinic

Berlin, 13353, Germany

RECRUITING

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

COMPLETED

University Clinic of Ruhr University Bochum

Herne, 44626, Germany

COMPLETED

European Institute of Oncology, Division of Gynecologic Oncology, Unit of Preventive Gynecology

Milan, 20100, Italy

WITHDRAWN

Related Publications (6)

• 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.

  PMID: 18245530 RESULT

• Konigsberg 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.

  PMID: 20167419 RESULT

• Obermayr 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.

  PMID: 21129172 RESULT

• Konigsberg 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.

  PMID: 21261508 RESULT

• Obermayr 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.

  PMID: 23017820 RESULT

• Hasenburg 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.

  PMID: 34530759 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Universal tumor bank

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Endocrine Gland Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Robert Zeillinger, Prof.Dr.

  Medical University Vienna, Dept. of Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Zeillinger, Prof. Dr.

CONTACT

+43140400; robert.zeillinger@meduniwien.ac.at

Eva Obermayr, PhD

CONTACT

+43140400; eva.obermayr@muv.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 8, 2013
• Study Start: November 1, 2003
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

IT (1); AU (1); BE (1); DE (3)