NCT04830332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 31, 2021

Last Update Submit

March 31, 2021

Conditions

Endometrial Carcinoma

Keywords

Endometrial carcinoma, CA-125, lymphovascular invasion

Outcome Measures

Primary Outcomes (1)

  • Abdominal washing fluid CA-125 levels

    One year

Study Arms (1)

Study group

OTHER

Women with endometrial carcinoma

Diagnostic Test: abdominal fluid CA-125 levels test

Interventions

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

Eligibility Criteria

Age55 Years - 68 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with endometrial carcinoma
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with endometrial carcinoma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Reseacrh Hospital

Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Suleyman G Doluoğlu

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologist

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)