Back to resultsCorrelation of Peritoneal Fluid CA-125 Levels With Postoperative Tumor Histology
Primary Purpose
Endometrial Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
abdominal fluid CA-125 levels test
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Carcinoma focused on measuring Endometrial carcinoma, CA-125, lymphovascular invasion
Eligibility Criteria
Inclusion Criteria:
- Women with endometrial carcinoma
Exclusion Criteria:
- 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
Sites / Locations
- Antalya Training and Reseacrh Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study group
Arm Description
Women with endometrial carcinoma
Outcomes
Primary Outcome Measures
Abdominal washing fluid CA-125 levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830332
Brief Title
Correlation of Peritoneal Fluid CA-125 Levels With Postoperative Tumor Histology
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2011 (Actual)
Primary Completion Date
December 1, 2012 (Actual)
Study Completion Date
December 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erdemli State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Carcinoma
Keywords
Endometrial carcinoma, CA-125, lymphovascular invasion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Other
Arm Description
Women with endometrial carcinoma
Intervention Type
Diagnostic Test
Intervention Name(s)
abdominal fluid CA-125 levels test
Intervention Description
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
Primary Outcome Measure Information:
Title
Abdominal washing fluid CA-125 levels
Time Frame
One year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with endometrial carcinoma
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with endometrial carcinoma
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suleyman G Doluoğlu
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Reseacrh Hospital
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Correlation of Peritoneal Fluid CA-125 Levels With Postoperative Tumor Histology
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