Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers

NCT ID: NCT03112733

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-04

Study Completion Date

2019-05-30

Brief Summary

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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

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Conditions

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Endometrial Neoplasms Ovarian Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

TFF3, SFRP4, Romo1, NFKB

Intervention Type DIAGNOSTIC_TEST

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.

TFF3, SFRP4, Romo1, NFKB

Intervention Type DIAGNOSTIC_TEST

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.

No interventions assigned to this group

Interventions

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TFF3, SFRP4, Romo1, NFKB

Blood samples of all participants will be collected.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role collaborator

Ilker Kahramanoglu

OTHER

Sponsor Role lead

Responsible Party

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Ilker Kahramanoglu

MD, Gynecologic Oncology Fellow

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ilker Kahramanoglu

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Cerrahpasa Medical Faculty

Macit Arvas

Role: STUDY_CHAIR

Istanbul University Cerrahpasa Medical Faculty

Fuat Demirkiran

Role: STUDY_DIRECTOR

Istanbul University Cerrahpasa Medical Faculty

Tugan Bese

Role: STUDY_DIRECTOR

Istanbul University Cerrahpasa Medical Faculty

Hasan Turan

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Cerrahpasa Medical Faculty

Hafize Uzun

Role: STUDY_DIRECTOR

Istanbul University Cerrahpasa Medical Faculty

Salvatore Giovanni Vitale

Role: STUDY_DIRECTOR

University of Messina

Locations

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Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 24951318 (View on PubMed)

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.

Reference Type RESULT
PMID: 25865689 (View on PubMed)

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.

Reference Type RESULT
PMID: 28319807 (View on PubMed)

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.

Reference Type RESULT
PMID: 27829249 (View on PubMed)

Other Identifiers

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TAB-2017-22506

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

83045809-604.01.02

Identifier Type: -

Identifier Source: org_study_id

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