Clinical trial NCT03112733: Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers
Official title: Value of TFF3, SFRP4, Romo1 and NFKB as Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Neoplasms
Ovarian Neoplasms
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2017-04-13
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 days
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Ilker Kahramanoglu
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Macit Arvas
role: STUDY_CHAIR
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Fuat Demirkiran
role: STUDY_DIRECTOR
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Tugan Bese
role: STUDY_DIRECTOR
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Hasan Turan
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Hafize Uzun
role: STUDY_DIRECTOR
affiliation: University of Messina
name: Salvatore Giovanni Vitale
role: STUDY_DIRECTOR
References:
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):175-81. doi: 10.1016/j.lungcan.2014.05.023. Epub 2014 Jun 5.
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. doi: 10.1016/s1499-3872(15)60352-6.
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 19.
citation: 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.