Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202512795843407 Date of Registration: 02/12/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Telomere Metrics in Transfusion-Dependent Thalassemia Patients
Official scientific title Telomere metrics in transfusion-dependent thalassemia patients
Brief summary describing the background and objectives of the trial Inherited hemoglobinopathies such as β-thalassemia cause chronic anemia and oxidative stress, which may accelerate biological aging by shortening telomeres. This study aims to quantify Human Telomerase levels in thalassemia patients compared to controls and examine the relationship between telomere metrics and hematological indices to understand disease severity and aging biomarkers in these patients.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2026
Actual trial start date
Anticipated date of last follow up 01/01/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Blood sampling for telomerase measurement in transfusion dependent beta thalassemia patients Single venous blood draw (~10 mL in EDTA tube) per participant One-time sample at enrollment Each participant diagnosed with transfusion-dependent β-thalassemia (confirmed by hemoglobin electrophoresis or genetic test), and on regular transfusions for at least one year, will provide a one-time 10 mL blood sample to assess telomerase by ELISA and other hematological indices, alongside collection of clinical and laboratory data. 30
Control Group Blood sampling for telomerase measurement in healthy controls Single venous blood draw (~10 mL in EDTA tube) per participant One-time sample at enrollment Age- and sex-matched healthy controls (no history of hematological disorders or chronic illnesses) will provide a one-time 10 mL blood sample, which will undergo the same laboratory tests as cases including telomerase measurement by ELISA, CBC, biochemical, and clinical indices. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Confirmed diagnosis of β-thalassemia major Age 5-40 years Regular follow-up at thalassemia clinic ≥1 year Stable transfusion regimen (1 transfusion every 4-6 weeks, past 6 months) Consent obtained from participant or guardian Recent malignancy or chemotherapy (past 12 months) Other chronic hematologic diseases Active/chronic infections or autoimmune diseases Bone marrow transplant or stem cell therapy history Use of antioxidant supplements (past 3 months) Pregnant or breastfeeding females Poor venous access or refusal to provide blood sample Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year 5 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/10/2025 Assiut University Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Assiut University Assiut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quantification of Human Telomerase levels in transfusion-dependent beta thalassemia patients compared to healthy controls At enrollment, single blood sample collection.
Secondary Outcome Correlation of telomere metrics with hematological indices such as hemoglobin, reticulocyte count, serum ferritin, and liver function among transfusion-dependent β-thalassemia patients At enrollment, single blood sample collection and baseline clinical data
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Hospitals Assiut University Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Abdallah Yousef Assiut University Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assiut University Assiut University Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdallah Yousef Abdallah.17289911@med.aun.edu.eg +201123243274 Assiut University
City Postal code Country Position/Affiliation
Assiut Egypt Assiut University
Role Name Email Phone Street address
Public Enquiries Eman Nasreldin emannasr@aun.edu.eg +201002677890 Assiut University
City Postal code Country Position/Affiliation
Assiut Egypt Assiut University
Role Name Email Phone Street address
Scientific Enquiries Mariam Ezzat mariamezzat2008@aun.edu.eg +201028158103 Assiut University
City Postal code Country Position/Affiliation
Assiut Egypt Assiut University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant-level data on telomerase levels, hematological indices, and patient demographics will be collected and shared upon reasonable request, ensuring patient confidentiality. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months after study completion Access granted to researchers upon approval of a formal request ensuring ethical use.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 20/11/2025 correction Single Group Parallel: different groups receive different interventions at same time during study
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/11/2025 correction TRUE, Assiut University Ethics Committee, Assiut University, Assiut, 71511, Egypt, , 01 Oct 2025, 0882411900, med@aun.edu.eg, TRUE, Assiut University Ethics Committee, Assiut University, Assiut, 71511, Egypt, , 01 Oct 2025, 0882411900, irbasyut@aun.edu.eg,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 20/11/2025 correction Self Funded, Assiut University, Assiut, , Egypt, Self Funded, Dr. Abdallah Yousef, Assiut University, Assiut, , Egypt, Self Funded,