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Establishment of a Tumor Bank for Blood Samples

NCT01763125RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Medical University of Vienna

Enrollment

10000

Start Date

2003-11-01

Completion Date

2026-12-01

Study Type

OBSERVATIONAL

Official Title

Establishment of a Blood Sample Bank in the Field of Gynaecological Oncology.

Interventions

Blood collection

Conditions

Ovarian NeoplasmsBreast NeoplasmsColorectal NeoplasmsNeoplasms of the Female GenitaliaLung NeoplasmsEndocrine Gland Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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

Time frame: 14 years

Locations

Innsbruck Medical University, Innsbruck, Austria

University Hospitals Leuven - Department of Obstetrics and Gynaecology, Leuven, Belgium

Charité University - Campus Virchow Chlinic, Berlin, Germany

University Medical Center Freiburg, Freiburg im Breisgau, Germany

University Clinic of Ruhr University Bochum, Herne, Germany

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

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Linked Papers

2021-09-16

Biomarker-based early detection of epithelial ovarian cancer based on a five-protein signature in patient’s plasma – a prospective trial

Abstract Background Trial on five plasma biomarkers (CA125, HE4, OPN, leptin, prolactin) and their possible role in differentiating benign from malignant ovarian tumors. Methods In this unicentric prospective trial preoperative blood samples of 43 women with ovarian masses determined for ovarian surgery were analyzed. 25 patients had pathologically confirmed benign, 18 malignant ovarian tumors. Blood plasma was analyzed for CA125, HE4, OPN, leptin, prolactin and MIF by multiplex immunoassay analysis. Each single protein and a logistical regression model including all the listed proteins were tested as preoperative predictive marker for suspect ovarian masses. Results Plasma CA125 was confirmed as a highly accurate tumor marker in ovarian cancer. HE4, OPN, leptin and prolactin plasma levels differed significantly between benign and malignant ovarian masses. With a logistical regression model a formula including CA125, HE4, OPN, leptin and prolactin was developed to predict malignant ovarian tumors. With a discriminatory AUC of 0.96 it showed to be a highly sensitive and specific diagnostic test for a malignant ovarian tumor. Conclusions The calculated formula with the combination of CA125, HE4, OPN, leptin and prolactin plasma levels surpasses each single marker in its diagnostic value to discriminate between benign and malignant ovarian tumors. The formula, applied to our patient population was highly accurate but should be validated in a larger cohort. Trial registration Clinical Trials.gov under NCT01763125, registered Jan. 8, 2013.

Linked Investigators

M. Bossart