Gynecologic CancerNCT03258307
Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Pre-post Omentectomy
A study testing Preoperative level in people with Gynecologic Cancer, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Preoperative level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 31 Dec 2018
- Phase
- Interventional
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gynecologic malignancy, staging surgery with or without omentectomy
Who cannot join
- not accept inclusion to trial
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, 34000
About this study
Official title: Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Derivated From Adipose Tissue Pre-postoperatively in Patient Diagnosed With Gynecological Malignancy Performed Omentectomy or Not
Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. These regulate matabolic process.
We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with gynecological malignancy performed omentectomy or not
Read the detailed description
Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. These regulate matabolic process.
We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with gynecological malignancy performed omentectomy or not. Blood sample will study after 4000 rpm centrifugal for 10 minutes
- Conditions
- Gynecologic Cancer
- Being tested
- Preoperative level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative levelOther
Also called Postoperative level
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| omentectomy | Active comparator | Preoperative Receives: Other: Preoperative level |
| Omentectomy | Other | Postoperative Receives: Other: Preoperative level |
| No omentectomy | Other | Preoperative post operative Receives: Other: Preoperative level |
What is being measured
The primary outcome is the main question the study is designed to answer.
with omentectomy group
Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
Measured: 1 year
No omentectomy group
Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
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 posted23 Aug 2017
- Study start1 Feb 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Isa Aykut Ozdemir, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258307
- Sponsor's protocol ID
- 900
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not share other researchers due to participant individual preference but when the research result publish researchers may obtain
Publications
Comba C, Ozdemir IA, Demirayak G, Erdogan SV, Demir O, Ozlem Yildiz G, Bulut H, Karakas S, Gulseren V, Afsar S, Gungorduk K. The effect of omentectomy on the blood levels of adipokines in obese patients with endometrial cancer. Obes Res Clin Pract. 2022 May-Jun;16(3):242-248. doi: 10.1016/j.orcp.2022.06.002. Epub 2022 Jun 11.
PubMed 35701296
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Derivated From Adipose Tissue Pre-postoperatively in Patient Diagnosed With Gynecological Malignancy Performed Omentectomy or Not
- ClinicalTrials.gov ID
- NCT03258307
- Acronym / sponsor ID
- 900
- Conditions
- Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Aug 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.
Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. These regulate matabolic process.
We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with gynecological malignancy performed omentectomy or not
Detailed description
Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. These regulate matabolic process.
We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with gynecological malignancy performed omentectomy or not. Blood sample will study after 4000 rpm centrifugal for 10 minutes
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| omentectomy | Active comparator | Other: Preoperative levelPreoperative |
| Omentectomy | Other | Other: Preoperative levelPostoperative |
| No omentectomy | Other | Other: Preoperative levelPreoperative post operative |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- gynecologic malignancy, staging surgery with or without omentectomy
Key exclusion criteria (1 listed)
- not accept inclusion to trial
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 |
|---|---|---|
| Preoperative levelAlso: Postoperative levelBlood sample | Other | No omentectomy, Omentectomy, omentectomy |
Primary outcome
with omentectomy group
Time frame: 1 year
Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
No omentectomy group
Time frame: 1 year
Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 35701296Comba C, Ozdemir IA, Demirayak G, Erdogan SV, Demir O, Ozlem Yildiz G, Bulut H, Karakas S, Gulseren V, Afsar S, Gungorduk K. The effect of omentectomy on the blood levels of adipokines in obese patients with endometrial cancer. Obes Res Clin Pract. 2022 May-Jun;16(3):242-248. doi: 10.1016/j.orcp.2022.06.002. Epub 2022 Jun 11.
- Individual participant dataSharing planned: No. IPD will not share other researchers due to participant individual preference but when the research result publish researchers may obtain
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative level in people with Gynecologic Cancer, run by Istanbul Training and Research Hospital 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 1 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: finished, as of the sponsor's last update on 6 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
with omentectomy group (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03258307, which also lists 1 linked publication.
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 6 Aug 2019.