Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers

Sponsor

Ilker Kahramanoglu (Other)

Overall Status

Unknown status

CT.gov ID

NCT03112733

Collaborator

Istanbul University (Other)

171

Enrollment

Location

25.8

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Neoplasms Ovarian Neoplasms	Diagnostic Test: TFF3, SFRP4, Romo1, NFKB

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

171 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 4, 2017

Actual Primary Completion Date :

Jun 21, 2018

Anticipated Study Completion Date :

May 30, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University Cerrahpasa Medical Faculty	Istanbul		Turkey	34303

Sponsors and Collaborators

Ilker Kahramanoglu
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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ilker Kahramanoglu, MD, Gynecologic Oncology Fellow, Istanbul University

ClinicalTrials.gov Identifier:

NCT03112733

Other Study ID Numbers:

83045809-604.01.02
TAB-2017-22506

First Posted:

Apr 13, 2017

Last Update Posted:

Feb 26, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Ovarian Neoplasms

Endometrial Neoplasms

Study Results

No Results Posted as of Feb 26, 2019