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

NCT02687321 | Unknown DMC

• 1 other identifier: HE4
• Study Type: observational
• Target: 150
• Locations: 6 countries
• Sites: 20

Brief 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.

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (2)

• Serum levels of tumor marker CA-125

  kU/l

  two years after study enrollment

• Serum levels of tumor marker HE4

  pmol/l

  two years after study enrollment

Secondary Outcomes (1)

• Ovarian cancer recurrence diagnosed by computed tomography scan

  two years after study enrollment

Study Arms (1)

Advanced ovarian cancer patients

Patient with histologically confirmed advanced (FIGO III and IV) epithelial ovarian, fallopian tube or primary peritoneal carcinoma with complete remission after first line treatment are included into the study. The patient is regularly followed up every 3-4 months, blood sample collection is performed to determinate tumor marker found in blood, elevated by the presence of cancer recurrence. In case of one or both of tumor markers are elevated, computed tomography examination with intravenous contrast agent of chest and abdomen is performed to detect the recurrence of the disease.

Other: Determination of CA 125 and HE4, Computed tomography

Interventions

Determination of CA 125 and HE4, Computed tomography OTHER

Blood sample collection to determinate tumor marker found in blood elevated by the presence of cancer recurrence.In case of one or both of tumor markers are elevated, computed tomography examination with intravenous contrast agent of chest and abdomen is performed to detect the recurrence of the disease.

Advanced ovarian cancer patients

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with histologically confirmed advanced epithelial ovarian, fallopian tube or primary peritoneal carcinoma with complete remission after first line treatment.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brno University Hospital: lead
• University Hospital Pilsen: collaborator

Study Sites (20)

Brno University Hospital

Brno, 62500, Czechia

RECRUITING

Hospital Ceske Budejovice

České Budějovice, 544256, Czechia

RECRUITING

Faculty Hospital in Hradec Králové

Hradec Králové, Czechia

RECRUITING

Hospital Jihlava

Jihlava, Czechia

RECRUITING

Faculty Hospital Pilsen

Pilsen, 30100, Czechia

RECRUITING

General Hospital Prague

Prague, 12000, Czechia

RECRUITING

Regional Hospital Pilsen

Zlín, 585068, Czechia

RECRUITING

University of Derecen

Debrecen, Hungary

RECRUITING

Swietokrzyskie Cancer Center

Kielce, 25734, Poland

RECRUITING

Cancer Center, M.Sklodowska-Curie Memorial Institute

Krakow, Poland

RECRUITING

Medical University of Lublin

Lublin, 20093, Poland

RECRUITING

Pomeranian Medical University

Szczecin, Poland

RECRUITING

Medical University of Warsaw

Warsaw, 02091, Poland

RECRUITING

Lower Silesian Cancer Center

Wroclaw, 58413, Poland

RECRUITING

Institute of Oncology, Bratislava

Bratislava, 81250, Slovakia

RECRUITING

National Institute of Oncology, Bratislava

Bratislava, 83310, Slovakia

RECRUITING

University Hospital Bratislava

Bratislava, Slovakia

RECRUITING

FN Trencín

Trenčín, 505820, Slovakia

RECRUITING

La Paz University Hospital. Madrid

Madrid, 28046, Spain

RECRUITING

Lviv State Regional Oncological Center

Lviv, Ukraine

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; 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

Study Officials

• Vit Weinberger, M.D., Ph.D.

  University Hospital Brno

  PRINCIPAL INVESTIGATOR

• Jiri Presl, M.D., Ph.D.

  University Hospital Pilsen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vit Weinberger, M.D., Ph.D.

CONTACT

+42053223; vit.weinberger@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 22, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (4); CZ (7); HU (1); PL (6); ES (1); UA (1)