NCT05546775

Brief Summary

Immunological profile and Clinical characteristics of children diagnosed with chronic granulomatous disease

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

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

August 30, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

August 30, 2022

Last Update Submit

September 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Immunological Profile and Clinical Characteristics of Children Diagnosed With Chronic Granulomatous Disease

    To describe the clinical characteristics and pattern of presentation of patients diagnosed as CGD in Assiut, and to find the most common presenting symptoms.and mention the immunological profile of patients diagnosed with CGD

    1 year

Interventions

DHRDIAGNOSTIC_TEST

To describe the clinical characteristics and pattern of presentation of patients diagnosed as CGD in Assiut, and to find the most common presenting symptoms. * To mention the immunological profile of patients diagnosed with CGD (Immunogloulins level - B, T, natural killer cells enumeration with flow cytometry- DHR123) * To assess the growth parameters in patients with CGD.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with diagnosed with CGD below 18 yrs

You may qualify if:

  • Age at enrollment less than18 years. Both genders. Diagnosed as probable CGD.

You may not qualify if:

  • Children above 18 years old. Children not fullfilling the criteria of CGD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • El-Mokhtar MA, Salama EH, Fahmy EM, Mohamed ME. "Clinical Aspects of Chronic Granulomatous Disease in Upper Egypt". Immunol Invest. 2021 Feb;50(2-3):139-151. doi: 10.1080/08820139.2020.1713144. Epub 2020 Jan 22.

  • Ko SH, Rhim JW, Shin KS, Hahn YS, Lee SY, Kim JG. Genetic analysis of CYBB gene in 26 korean families with X-linked chronic granulomatous disease. Immunol Invest. 2014;43(6):585-94. doi: 10.3109/08820139.2013.825270.

  • Monies D, Abouelhoda M, AlSayed M, Alhassnan Z, Alotaibi M, Kayyali H, Al-Owain M, Shah A, Rahbeeni Z, Al-Muhaizea MA, Alzaidan HI, Cupler E, Bohlega S, Faqeih E, Faden M, Alyounes B, Jaroudi D, Goljan E, Elbardisy H, Akilan A, Albar R, Aldhalaan H, Gulab S, Chedrawi A, Al Saud BK, Kurdi W, Makhseed N, Alqasim T, El Khashab HY, Al-Mousa H, Alhashem A, Kanaan I, Algoufi T, Alsaleem K, Basha TA, Al-Murshedi F, Khan S, Al-Kindy A, Alnemer M, Al-Hajjar S, Alyamani S, Aldhekri H, Al-Mehaidib A, Arnaout R, Dabbagh O, Shagrani M, Broering D, Tulbah M, Alqassmi A, Almugbel M, AlQuaiz M, Alsaman A, Al-Thihli K, Sulaiman RA, Al-Dekhail W, Alsaegh A, Bashiri FA, Qari A, Alhomadi S, Alkuraya H, Alsebayel M, Hamad MH, Szonyi L, Abaalkhail F, Al-Mayouf SM, Almojalli H, Alqadi KS, Elsiesy H, Shuaib TM, Seidahmed MZ, Abosoudah I, Akleh H, AlGhonaium A, Alkharfy TM, Al Mutairi F, Eyaid W, Alshanbary A, Sheikh FR, Alsohaibani FI, Alsonbul A, Al Tala S, Balkhy S, Bassiouni R, Alenizi AS, Hussein MH, Hassan S, Khalil M, Tabarki B, Alshahwan S, Oshi A, Sabr Y, Alsaadoun S, Salih MA, Mohamed S, Sultana H, Tamim A, El-Haj M, Alshahrani S, Bubshait DK, Alfadhel M, Faquih T, El-Kalioby M, Subhani S, Shah Z, Moghrabi N, Meyer BF, Alkuraya FS. The landscape of genetic diseases in Saudi Arabia based on the first 1000 diagnostic panels and exomes. Hum Genet. 2017 Aug;136(8):921-939. doi: 10.1007/s00439-017-1821-8. Epub 2017 Jun 9.

  • Boonyawat B, Suksawat Y, Pacharn P, Suwanpakdee P, Traivaree C. X-Linked Chronic Granulomatous Disease: Initial Presentation with Intracranial Hemorrhage from Vitamin K Deficiency in Infant. Case Rep Pediatr. 2018 Jun 24;2018:7041204. doi: 10.1155/2018/7041204. eCollection 2018.

  • Wakabayashi Y, Jubishi D, Okamoto K, Ikeda M, Tatsuno K, Mizoguchi M, Sato T, Okugawa S, Moriya K. A rare case of a prostatic abscess, bacteremia and chronic granulomatous disease associated with Klebsiella pneumoniae. J Infect Chemother. 2019 May;25(5):365-367. doi: 10.1016/j.jiac.2018.11.015. Epub 2019 Jan 11.

  • Falcone EL, Holland SM. Invasive fungal infection in chronic granulomatous disease: insights into pathogenesis and management. Curr Opin Infect Dis. 2012 Dec;25(6):658-69. doi: 10.1097/QCO.0b013e328358b0a4.

  • El Hawary R, Meshaal S, Deswarte C, Galal N, Abdelkawy M, Alkady R, Elaziz DA, Freiberger T, Ravcukova B, Litzman J, Bustamante J, Boutros J, Gaafar T, Elmarsafy A. Role of Flow Cytometry in the Diagnosis of Chronic Granulomatous Disease: the Egyptian Experience. J Clin Immunol. 2016 Aug;36(6):610-8. doi: 10.1007/s10875-016-0297-y. Epub 2016 May 24.

  • Roesler J, Hecht M, Freihorst J, Lohmann-Matthes ML, Emmendorffer A. Diagnosis of chronic granulomatous disease and of its mode of inheritance by dihydrorhodamine 123 and flow microcytofluorometry. Eur J Pediatr. 1991 Jan;150(3):161-5. doi: 10.1007/BF01963557.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Immunological profile and Clinical characteristics of children diagnosed with chronic granulomatous disease

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 21, 2022

Study Start

September 20, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2024

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share