Endometrial CarcinomaNCT04830332
Correlation of Peritoneal Fluid CA-125 Levels With Postoperative Tumor Histology
A study testing abdominal fluid CA-125 levels test in people with Endometrial Carcinoma, run by Erdemli State Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective study, we aimed to investigate whether serum and abdominal washing fluid CA-125 levels correlated with postoperative histopathological parameters in patients with endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 55 to 68 years, women only
- Conditions the study is for
- Endometrial Carcinoma
- What is being tested?
- abdominal fluid CA-125 levels test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2011to 1 Dec 2012
- 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 55 to 68 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with endometrial carcinoma
Who cannot join
- Previous history of any other malignancy
- Endometriosis
- Diagnosed with pelvic infection or with any other potential disease such as acute pancreatitis, colitis, diverticulitis, pericarditis, polyarteritis nodosa, Sjögren's syndrome and SLE
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Reseacrh Hospital
Antalya, 07100
About this study
Official title: Correlation of Preoperative Serum and Intraoperative Peritoneal Washing Fluid CA-125 Levels With Postoperative Tumor Histology in Patients With Endometrial Carcinoma: a Prospective-controlled Study
In this prospective study, we aimed to investigate whether serum and abdominal washing fluid CA-125 levels correlated with postoperative histopathological parameters in patients with endometrial carcinoma.
Read the detailed description
Endometrial cancer was diagnosed with histopathological examination of the samples obtained by dilatation and curettage. Preoperative serum CA-125 levels were determined in all patients. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. In addition to routine preoperative investigations, MRI was done in patients who were thought to have an extension outside the uterus.
During surgery, abdominal exploration was performed first, and then an abdominal fluid sample was obtained for cytological examination and measurement of CA-125 level. One hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Subsequently, total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH + BSO) were performed.
- Conditions
- Endometrial Carcinoma
- Being tested
- abdominal fluid CA-125 levels test
- Keywords
- Endometrial carcinoma, CA-125, lymphovascular invasion
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal fluid CA-125 levels testDiagnostic test
One hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. I
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | Women with endometrial carcinoma Receives: Diagnostic Test: abdominal fluid CA-125 levels test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal washing fluid CA-125 levels
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Dec 2011
- Primary completion1 Dec 2012
- Study completion1 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erdemli State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Gunhan Doluoglu, Erdemli State Hospital
- Investigators
- Suleyman G Doluoğlu, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830332
- Sponsor's protocol ID
- CA125
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Preoperative Serum and Intraoperative Peritoneal Washing Fluid CA-125 Levels With Postoperative Tumor Histology in Patients With Endometrial Carcinoma: a Prospective-controlled Study
- ClinicalTrials.gov ID
- NCT04830332
- Acronym / sponsor ID
- CA125
- Conditions
- Endometrial Carcinoma
- Keywords
- Endometrial carcinoma, CA-125, lymphovascular invasion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Erdemli State HospitalUniversity, hospital or other
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 1 Dec 2012 (actual)
- First posted
- 5 Apr 2021 (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.
In this prospective study, we aimed to investigate whether serum and abdominal washing fluid CA-125 levels correlated with postoperative histopathological parameters in patients with endometrial carcinoma.
Detailed description
Endometrial cancer was diagnosed with histopathological examination of the samples obtained by dilatation and curettage. Preoperative serum CA-125 levels were determined in all patients. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. In addition to routine preoperative investigations, MRI was done in patients who were thought to have an extension outside the uterus.
During surgery, abdominal exploration was performed first, and then an abdominal fluid sample was obtained for cytological examination and measurement of CA-125 level. One hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Subsequently, total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH + BSO) were performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Diagnostic Test: abdominal fluid CA-125 levels testWomen with endometrial carcinoma |
Who may qualify
- Ages
- 55 to 68 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with endometrial carcinoma
Key exclusion criteria (3 listed)
- Previous history of any other malignancy
- Endometriosis
- Diagnosed with pelvic infection or with any other potential disease such as acute pancreatitis, colitis, diverticulitis, pericarditis, polyarteritis nodosa, Sjögren's syndrome and SLE
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 |
|---|---|---|
| abdominal fluid CA-125 levels testOne hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. I | Diagnostic test | Study group |
Primary outcome
Abdominal washing fluid CA-125 levels
Time frame: One year
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 5 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Endometrial Carcinoma
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Suleyman G Doluoğlu principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal fluid CA-125 levels test in people with Endometrial Carcinoma, run by Erdemli State 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 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: finished, as of the sponsor's last update on 5 Apr 2021. 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?
Abdominal washing fluid CA-125 levels (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2021.