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The Role of HE4 in the Follow-up of Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer

NCT02687321UNKNOWNOBSERVATIONAL

Summary

To evaluate and to compare the effectiveness of CA-125 and HE4 serum levels in epithelial ovarian cancer (OC) in follow-up in terms of time to detection of elevation after the end of the first line treatment. To evaluate the lead-time of the rise of marker levels before epithelial OC recurrence diagnosis by Computed tomography (CT) imaging method. To evaluate the appropriate HE4 cut-off value for follow-up of patients after the treatment of ovarian, Fallopian tube and primary peritoneal cancer.

Key Facts

Lead Sponsor

Brno University Hospital

Enrollment

150

Start Date

2016-04-01

Completion Date

2020-01-01

Study Type

OBSERVATIONAL

Official Title

The Role of HE4 in the Follow-up of Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer: First Prospective Multicentre Observational Study

Interventions

Determination of CA 125 and HE4Computed tomography

Conditions

Ovarian Neoplasms

Eligibility

Sex

FEMALE

Inclusion Criteria:

* advanced ovarian cancer, stage FIGO III and IV
* histology types: high-grade serous, low-grade serous, endometrioid, clear cell, undifferentiated
* completed ovarian cancer surgery and platinum-based chemotherapy

Exclusion Criteria:

* positivity of tumor markers CA 125 and HE4 during study enrollment
* signs of cancer at computed tomography scan during study enrollment

Outcome Measures

Primary Outcomes

Serum levels of tumor marker CA-125

kU/l

Time frame: two years after study enrollment

Serum levels of tumor marker HE4

pmol/l

Time frame: two years after study enrollment

Secondary Outcomes

Ovarian cancer recurrence diagnosed by computed tomography scan

Time frame: two years after study enrollment

Locations

Brno University Hospital, Brno, Czechia

Hospital Ceske Budejovice, České Budějovice, Czechia

Faculty Hospital in Hradec Králové, Hradec Králové, Czechia

Hospital Jihlava, Jihlava, Czechia

Faculty Hospital Pilsen, Pilsen, Czechia

General Hospital Prague, Prague, Czechia

Regional Hospital Pilsen, Zlín, Czechia

University of Derecen, Debrecen, Hungary

Swietokrzyskie Cancer Center, Kielce, Poland

Cancer Center, M.Sklodowska-Curie Memorial Institute, Krakow, Poland

Medical University of Lublin, Lublin, Poland

Pomeranian Medical University, Szczecin, Poland

Medical University of Warsaw, Warsaw, Poland

Lower Silesian Cancer Center, Wroclaw, Poland

Institute of Oncology, Bratislava, Bratislava, Slovakia

National Institute of Oncology, Bratislava, Bratislava, Slovakia

University Hospital Bratislava, Bratislava, Slovakia

FN Trencín, Trenčín, Slovakia

La Paz University Hospital. Madrid, Madrid, Spain

Lviv State Regional Oncological Center, Lviv, Ukraine

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.