Serum NGAL as a Predictor of Clinical and Endoscopic Acti... | NCT05151458

Studies
Serum NGAL as a Predictor of Clinical and Endoscopic Activity of Inflammatory Bowel Disease

NCT05151458

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 14, 2021Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Not provided

Countries

Not provided

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 29, 2021Estimated

Primary Completion Date

Nov 29, 2022Estimated

Completion Date

Nov 30, 2022Estimated

First Submitted Date

Nov 29, 2021

First Submission Date that Met QC Criteria

Nov 29, 2021

First Posted Date

Dec 9, 2021Actual

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

Dec 12, 2021

Last Update Posted Date

Dec 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Alsadek Mahmoud Ghozaly, Serum NGAL as a predictor of clinical and endoscopic activity of inflammatory bowel disease, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Ulcerative colitis (UC) and Crohns disease (CD) represent the two major forms of inflammatory bowel disease (IBD), characterized by epithelial cell damage and prominent mucosal infiltration by inflammatory cells including granulocytes, macrophages, lymphocytes, and plasma cells.

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

No data available

No data is available for this block.

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
test the sensitivity and specificity of using NGAL in diagnosis of IBD	test the sensitivity and specificity of using NGAL in diagnosis of IBD	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: IBD patients diagnosed by endoscopy.

Male and female gender. Disease activity proven clinically and endoscopy . Assiut university hospital patients

Exclusion Criteria:

Patients who refuse to contribute in this study Pregnancy and breast feeding Cancer patients Renal pathology Diabetes Mellitus Cardiovascular patients Pancreatitis COPD patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adults with IBD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Alsadek Ma Ghozaly, Master	Contact	01150993206		alsadekmohamed215@gmail.com
Hossam Ma Abd Alwahab	Contact	01146539976

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22200942	Background	Oikonomou KA, Kapsoritakis AN, Theodoridou C, Karangelis D, Germenis A, Stefanidis I, Potamianos SP. Neutrophil gelatinase-associated lipocalin (NGAL) in inflammatory bowel disease: association with pathophysiology of inflammation, established markers, and disease activity. J Gastroenterol. 2012 May;47(5):519-30. doi: 10.1007/s00535-011-0516-5. Epub 2011 Dec 27.
31361991

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases