NCT03112733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

April 4, 2017

Last Update Submit

February 25, 2019

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (1)

  • 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

Study Arms (3)

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

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

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.

Interventions

TFF3, SFRP4, Romo1, NFKBDIAGNOSTIC_TEST

Blood samples of all participants will be collected.

Control groupPatients with ovarian carcinoma

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Primary diagnosis of epithelial ovarian carcinoma.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (4)

  • 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):175-81. doi: 10.1016/j.lungcan.2014.05.023. Epub 2014 Jun 5.

    PMID: 24951318RESULT

  • 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. doi: 10.1016/s1499-3872(15)60352-6.

    PMID: 25865689RESULT

  • 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 19.

    PMID: 28319807RESULT

  • Edfeldt K, Daskalakis K, Backlin C, Norlen O, Tiensuu Janson E, Westin G, Hellman P, Stalberg P. DcR3, TFF3, and Midkine Are Novel Serum Biomarkers in Small Intestinal Neuroendocrine Tumors. Neuroendocrinology. 2017;105(2):170-181. doi: 10.1159/000452891. Epub 2016 Nov 9.

    PMID: 27829249RESULT

MeSH Terms

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Ilker Kahramanoglu

    Istanbul University Cerrahpasa Medical Faculty

    PRINCIPAL INVESTIGATOR

  • Macit Arvas

    Istanbul University Cerrahpasa Medical Faculty

    STUDY CHAIR

  • Fuat Demirkiran

    Istanbul University Cerrahpasa Medical Faculty

    STUDY DIRECTOR

  • Tugan Bese

    Istanbul University Cerrahpasa Medical Faculty

    STUDY DIRECTOR

  • Hasan Turan

    Istanbul University Cerrahpasa Medical Faculty

    PRINCIPAL INVESTIGATOR

  • Hafize Uzun

    Istanbul University Cerrahpasa Medical Faculty

    STUDY DIRECTOR

  • Salvatore Giovanni Vitale

    University of Messina

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Gynecologic Oncology Fellow

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 13, 2017

Study Start

April 4, 2017

Primary Completion

June 21, 2018

Study Completion

May 30, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

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

Locations

TU(1)