Beta-ThalassemiaNCT03894605
Dermatological Abnormalities in Beta-thalassemia Major
An observational study of Beta-Thalassemia, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Beta-Thalassemia
- What is being tested?
- thalassemia
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2020to 2 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: all patient examined by single dermatologist to record any dermatological abnormalities
Who may be able to join
None listed.
Who cannot join
- patient with other hemolytic anemia. childern with any abnormalities prior to the diagnosis of thalassemi
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital
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
Read the detailed description
thalassemia refers to agroup of inherited disease characterized by decreased or absent synthesis of normal globin .skinvdisorders are usually neglected and frequently underdiagnosed among these patients.skin disease specially pruritus and xerosis are observed highly frequently in patients with beta-thalassemia.pityriasis alba is arelatively common skin disorder.the trophic skin changes and leg ulcers occurred after the age of 15 years
- Conditions
- Beta-Thalassemia
- Being tested
- thalassemia
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalassemiaDevice
thalassemic patient use chelator and thaladssemic patient with frequent blood transfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start2 Mar 2020 (estimated)
- Primary completion2 Mar 2021 (estimated)
- Study completion2 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Beta-ThalassemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Mamdoh Farag, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894605
- Sponsor's protocol ID
- DBTM
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed.
PubMed 20098328El-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.
PubMed 29943859Dogramaci 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.
PubMed 19785086CHANG PY, KUO CL, KHOO FY. The anatomic distribution of the lesions in pulmonary tuberculosis. Med Abstr. 1945 Oct;63A:237-43. No abstract available.
PubMed 20997138
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment ofDermatological Abnrmalities in Beta-thalassemia Major in Assiut University Pediatric Hospital
- ClinicalTrials.gov ID
- NCT03894605
- Acronym / sponsor ID
- DBTM
- Conditions
- Beta-Thalassemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Mar 2020 (estimated)
- Primary completion
- 2 Mar 2021 (estimated)
- Study completion
- 2 Apr 2021 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
thalassemia refers to agroup of inherited disease characterized by decreased or absent synthesis of normal globin .skinvdisorders are usually neglected and frequently underdiagnosed among these patients.skin disease specially pruritus and xerosis are observed highly frequently in patients with beta-thalassemia.pityriasis alba is arelatively common skin disorder.the trophic skin changes and leg ulcers occurred after the age of 15 years
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- all patient examined by single dermatologist to record any dermatological abnormalities
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- patient with other hemolytic anemia. childern with any abnormalities prior to the diagnosis of thalassemi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thalassemiathalassemic patient use chelator and thaladssemic patient with frequent blood transfusion | Device | – |
Primary outcome
The percentage of patients with dermatological disorders due to iron overload Iron overload cause dermatological abnormalities
Time frame: one month
the number of patients who develop any dermatological disorder as a result of iron overload after frequent blood transfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Background: PubMed 20098328Cao A, Galanello R. Beta-thalassemia. Genet Med. 2010 Feb;12(2):61-76. doi: 10.1097/GIM.0b013e3181cd68ed.
- Results publication: PubMed 29943859El-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.
- Results publication: PubMed 19785086Dogramaci 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.
- Results publication: PubMed 20997138CHANG PY, KUO CL, KHOO FY. The anatomic distribution of the lesions in pulmonary tuberculosis. Med Abstr. 1945 Oct;63A:237-43. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Beta-Thalassemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alsayed khalil Abd elkareem, Professor (01060805170, Khalilsay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with dermatological disorders due to iron overload Iron overload cause dermatological abnormalities (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894605, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.