Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03112733
• Other study ID #: 83045809-604.01.02
• Secondary ID: TAB-2017-22506
• Status: Active, not recruiting
• Start date: April 4, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: February 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 171
• Est. completion date: May 30, 2019
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Neoplasms
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• TFF3, SFRP4, Romo1, NFKB
Blood samples of all participants will be collected.

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Ilker Kahramanoglu	Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Edfeldt K, Daskalakis K, Bäcklin C, Norlén O, Tiensuu Janson E, Westin G, Hellman P, Stålberg P. DcR3, TFF3, and Midkine Are Novel Serum Biomarkers in Small Intestinal Neuroendocrine Tumors. Neuroendocrinology. 2017;105(2):170-181. doi: 10.1159/000452891. — View Citation

Lee SH, Lee JS, Lee EJ, Min KH, Hur GY, Lee SH, Lee SY, Kim JH, Lee SY, Shin C, Shim JJ, Kang KH, In KH. Serum reactive oxygen species modulator 1 (Romo1) as a potential diagnostic biomarker for non-small cell lung cancer. Lung Cancer. 2014 Aug;85(2):175- — View Citation

Nunes JJ, Pandey SK, Yadav A, Goel S, Ateeq B. Targeting NF-kappa B Signaling by Artesunate Restores Sensitivity of Castrate-Resistant Prostate Cancer Cells to Antiandrogens. Neoplasia. 2017 Apr;19(4):333-345. doi: 10.1016/j.neo.2017.02.002. Epub 2017 Mar — View Citation

Xu C, Zeng XH, Wang L, Tao SQ, Wu QX, Zhu P, Deng GH, Wang YM. sFRP-4, a potential novel serum marker for chronic hepatitis B-related hepatocellular carcinoma. Hepatobiliary Pancreat Dis Int. 2015 Apr;14(2):164-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)-?b in discrimination of benign and malignant gynecologic disease	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)-?B between groups and to identify a possible significant diagnostic marker	2 days
Secondary	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)-?b in predicting overall survival and disease-free survival	To determine any relationship between prognosis of ovarian cancer and serum levels of four different biomarkers	1 year