NCT03894605

Brief Summary

to study the frequency and pattern of dermatological abnormalities in egyptian childern with beta thalassemia.relationof abnormalities to duration of disease and frequency of transfusion

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
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

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

March 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 22, 2019

Last Update Submit

March 27, 2019

Conditions

Beta-Thalassemia

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with dermatological disorders due to iron overload Iron overload cause dermatological abnormalities

    the number of patients who develop any dermatological disorder as a result of iron overload after frequent blood transfusion

    one month

Interventions

thalassemiaDEVICE

thalassemic patient use chelator and thaladssemic patient with frequent blood transfusion

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all patient examined by single dermatologist to record any dermatological abnormalities

You may not qualify if:

  • patient with other hemolytic anemia. childern with any abnormalities prior to the diagnosis of thalassemi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed.

    PMID: 20098328BACKGROUND

  • El-Dash H, Adel S. Cutaneous manifestations in Egyptian children with beta-thalassemia major: Relationship with serum ferritin, thyroid profile, and treatment modalities. Pediatr Dermatol. 2018 Sep;35(5):639-643. doi: 10.1111/pde.13570. Epub 2018 Jun 26.

    PMID: 29943859RESULT

  • Dogramaci AC, Savas N, Ozer B, Duran N. Skin diseases in patients with beta-thalassemia major. Int J Dermatol. 2009 Oct;48(10):1057-61. doi: 10.1111/j.1365-4632.2009.04176.x.

    PMID: 19785086RESULT

  • CHANG PY, KUO CL, KHOO FY. The anatomic distribution of the lesions in pulmonary tuberculosis. Med Abstr. 1945 Oct;63A:237-43. No abstract available.

    PMID: 20997138RESULT

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Alsayed khalil Abd elkareem, Professor

CONTACT

01060805170Khalilsay@gmail.com

Mostafa Mohamed, Lecturer

CONTACT

01006244311Mustafa-embaby@aun.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 28, 2019

Study Start

March 2, 2020

Primary Completion

March 2, 2021

Study Completion

April 2, 2021

Last Updated

March 28, 2019

Record last verified: 2019-03