Relationship of Endometrial Cancer and Serum Soluble L1CA... | NCT04603599

Studies
Relationship of Endometrial Cancer and Serum Soluble L1CAM Level

NCT04603599

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Nov 2, 2020Actual

Enrollment

146Actual

Phase

Not provided

Conditions

Endometrium Cancer

Interventions

serum soluble L1CAM (sL1CAM)

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Oct 14, 2020

First Submission Date that Met QC Criteria

Oct 24, 2020

First Posted Date

Oct 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2020

Last Update Posted Date

Nov 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes, endometrial hyperplasia, or endometrial cancer. The sL1CAM level between groups will be compared. The relationship between prognostic factors and serum sL1CAM will be evaluated in patients with endometrial cancer.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
benign endometrial changes			Diagnostic Test: serum soluble L1CAM (sL1CAM)
endometrial hyperplasia			Diagnostic Test: serum soluble L1CAM (sL1CAM)
endometrial cancer			Diagnostic Test: serum soluble L1CAM (sL1CAM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum soluble L1CAM (sL1CAM)	Diagnostic Test	blood sample	benign endometrial changes endometrial cancer endometrial hyperplasia

Measure	Description	Time Frame
serum sL1CAM level		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent endometrial biopsy due to abnormal uterine bleeding and whose pathology results were reported as benign endometrial changes, endometrial hyperplasia or endometrial cancer were included in the study. All patients participating in the study signed informed consent.

Exclusion Criteria:

Patients who did not have consent, received neoadjuvant therapy and who would not have surgery despite endometrial cancer were excluded from the study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

benign endometrial changes, endometrial hyperplasia or endometrial cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Merve Demir		Kocaeli		41000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided