NCT05151458

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

December 29, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

November 29, 2021

Last Update Submit

December 12, 2021

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with IBD

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22200942BACKGROUND

  • Nakov R. New markers in ulcerative colitis. Clin Chim Acta. 2019 Oct;497:141-146. doi: 10.1016/j.cca.2019.07.033. Epub 2019 Jul 27.

    PMID: 31361991BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Mohamed Alsadek Ma Ghozaly, Master

CONTACT

01150993206alsadekmohamed215@gmail.com

Hossam Ma Abd Alwahab

CONTACT

01146539976

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Serum NGAL as a predictor of clinical and endoscopic activity of inflammatory bowel disease

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 9, 2021

Study Start

December 29, 2021

Primary Completion

November 29, 2022

Study Completion

November 30, 2022

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share