Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers

• Conditions: Ovarian Neoplasms; Endometrial Neoplasms
• Interventions: Diagnostic Test: TFF3, SFRP4, Romo1, NFKB

• Registration Number: NCT03112733
• Lead Sponsor: Ilker Kahramanoglu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Primary Completion: 2018-06-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 171

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	TFF3, SFRP4, Romo1, NFKB	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.
Patients with ovarian carcinoma	TFF3, SFRP4, Romo1, NFKB	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.

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
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	1 year	To determine any relationship between prognosis of ovarian cancer and serum levels of four different biomarkers

Trial Locations

Locations (1)

Istanbul University Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey