Endometrial NeoplasmsNCT03112733
Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers
An observational study of Endometrial Neoplasms and Ovarian Neoplasms, run by Ilker Kahramanoglu at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Neoplasms, Ovarian Neoplasms
- What is being tested?
- TFF3, SFRP4, Romo1, NFKB
- How many people
- 171 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2017to 30 May 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Primary diagnosis of epithelial ovarian carcinoma.
Who cannot join
- Patients with recurrence.
- Patients who received neoadjuvant chemotherapy or radiotherapy
- Presence of any secondary malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34303
About this study
Official title: Value of TFF3, SFRP4, Romo1 and NFKB as Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers
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.
- Conditions
- Endometrial Neoplasms, Ovarian Neoplasms
- Being tested
- TFF3, SFRP4, Romo1, NFKB
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFF3, SFRP4, Romo1, NFKBDiagnostic test
Blood samples of all participants will be collected.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To determine any relationship between prognosis of ovarian cancer and serum levels of four different biomarkers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start4 Apr 2017
- Primary completion21 Jun 2018
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ilker Kahramanoglu
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Sponsor-investigator, Ilker Kahramanoglu, Istanbul University
- Investigators
- Ilker Kahramanoglu, Principal investigator, Istanbul University Cerrahpasa Medical FacultyMacit Arvas, Study chair, Istanbul University Cerrahpasa Medical FacultyFuat Demirkiran, Study director, Istanbul University Cerrahpasa Medical FacultyTugan Bese, Study director, Istanbul University Cerrahpasa Medical FacultyHasan Turan, Principal investigator, Istanbul University Cerrahpasa Medical FacultyHafize Uzun, Study director, Istanbul University Cerrahpasa Medical FacultySalvatore Giovanni Vitale, Study director, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112733
- Sponsor's protocol ID
- 83045809-604.01.02
- Other IDs
- TAB-2017-22506
- Status last verified
- Feb 2019
- First submitted
- 4 Apr 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data may be shared with researchers planning to perform a metaanalysis.
Publications
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.
PubMed 24951318Xu 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.
PubMed 25865689Nunes 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.
PubMed 28319807Edfeldt 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.
PubMed 27829249
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of TFF3, SFRP4, Romo1 and NFKB as Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers
- ClinicalTrials.gov ID
- NCT03112733
- Acronym / sponsor ID
- 83045809-604.01.02
- Conditions
- Endometrial Neoplasms, Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Ilker KahramanogluUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with ovarian carcinoma | – | Diagnostic Test: TFF3, SFRP4, Romo1, NFKBSerum 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. |
| Control group | – | Diagnostic Test: TFF3, SFRP4, Romo1, NFKBSerum 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Primary diagnosis of epithelial ovarian carcinoma.
Key exclusion criteria (3 listed)
- Patients with recurrence.
- Patients who received neoadjuvant chemotherapy or radiotherapy
- Presence of any secondary malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFF3, SFRP4, Romo1, NFKBBlood samples of all participants will be collected. | Diagnostic test | Control group, Patients with ovarian carcinoma |
Primary outcome
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
Time frame: 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
1 secondary outcome
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
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Results publication: PubMed 24951318Lee 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.
- Results publication: PubMed 25865689Xu 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.
- Results publication: PubMed 28319807Nunes 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.
- Results publication: PubMed 27829249Edfeldt 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.
- Individual participant dataSharing planned: Yes. All data may be shared with researchers planning to perform a metaanalysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Kahramanoglu principal investigator
Istanbul University Cerrahpasa Medical Faculty
Macit Arvas study chair
Istanbul University Cerrahpasa Medical Faculty
Fuat Demirkiran study director
Istanbul University Cerrahpasa Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms and Ovarian Neoplasms, run by Ilker Kahramanoglu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112733, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.