Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers

February 25, 2019 updated by: Ilker Kahramanoglu

Value of TFF3, SFRP4, Romo1 and NFKB as Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers

This study evaluates the usefulness of serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB as potential diagnostic and prognostic biomarkers in ovarian carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Istanbul University Cerrahpasa Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with ovarian carcinoma who will be operated in Cerrahpasa Medical Faculty, Division of Gynecologic Oncology will participate into the study. Additionally, women without any malignancy will participate as control group.

Description

Inclusion Criteria:

  • Primary diagnosis of epithelial ovarian carcinoma.

Exclusion Criteria:

  • Patients with recurrence.
  • Patients who received neoadjuvant chemotherapy or radiotherapy
  • Presence of any secondary malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with ovarian carcinoma
Serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB of patients with a presumed diagnosis of ovarian carcinoma will be determined prior to surgery.
Diagnostic test: TFF3, SFRP4, Romo1, NFKB
Blood samples of all participants will be collected.
Control group
Serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB of women without any adnexal mass nor malignancy will be determined to compare with other groups.
Diagnostic test: TFF3, SFRP4, Romo1, NFKB
Blood samples of all participants will be collected.
Benign adnexal mass
Serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB of women with an adnexal mass will be determined to compare with other groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-Κb in discrimination of benign and malignant gynecologic disease
Time Frame: 2 days
To measure serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB between groups and to identify a possible significant diagnostic marker
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-Κb in predicting overall survival and disease-free survival
Time Frame: 1 year
To determine any relationship between prognosis of ovarian cancer and serum levels of four different biomarkers
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilker Kahramanoglu

Collaborators

Istanbul University

Investigators

  • Principal Investigator: Ilker Kahramanoglu, Istanbul University Cerrahpasa Medical Faculty
  • Study Chair: Macit Arvas, Istanbul University Cerrahpasa Medical Faculty
  • Study Director: Fuat Demirkiran, Istanbul University Cerrahpasa Medical Faculty
  • Study Director: Tugan Bese, Istanbul University Cerrahpasa Medical Faculty
  • Principal Investigator: Hasan Turan, Istanbul University Cerrahpasa Medical Faculty
  • Study Director: Hafize Uzun, Istanbul University Cerrahpasa Medical Faculty
  • Study Director: Salvatore Giovanni Vitale, University of Messina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 4, 2017

Primary Completion (ACTUAL)

June 21, 2018

Study Completion (ANTICIPATED)

May 30, 2019

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (ACTUAL)

April 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83045809-604.01.02
  • TAB-2017-22506 (OTHER_GRANT: Istanbul University, Scientific Research Projects)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data may be shared with researchers planning to perform a metaanalysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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