TGF β 1 Expression Related Gene Polymorphism

NCT06683690 | Recruiting DMC

• 1 other identifier: Gehad Adel Abd El-Sabour
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Leprosy is one of the oldest human infectious diseases. It is a chronic infectious contagious, granulomatous disease caused by intracellular bacillus. Mycobacterium leprae, this chronic granulomatous disease presents symptoms that mainly affected the skin, the nervous system and the reticuloendothelial system, also other systems can be affected, such as the upper respiratory tract, bones and joints, eyes and adrenal glands. TGF- β is a pleiotropic cytokine that employs several functions on different types of cells. The effect of other cytokines may finally modulate the cellular response in the presence of TGF- β, causing a different effect depending on the activation state of the cell involved. In addition, TGF- β promotes the healing of inflamed tissue through the stimulation and regulation of extracellular matrix by fibroblasts, in addition to inducing the proliferation of endothelial cells required for angiogenesis. Thus, TGF- β is able to regulate the expression of other growth factors, increasing their level of activity.

Conditions

Leprosy

Outcome Measures

Primary Outcomes (1)

• Detection of serum TGF β1

  Detection of serum TGF β1 in leprosy patients and Correlate them with different clinical types of leprosy by taking Blood Samples will be collected from the patients to detect TGF β1gene by DNA extraction and SNP genotyping - Genomic DNA will be extracted from peripheral blood samples, then the polymorphism of the TGF β1 gene marker will be selected, The Blood Samples will be collected from the patients before and after treatment with multidrug therapy of leprosy to detect the level of TGF β1 concentrations by ELISA.

  One Year

Study Arms (2)

Group A: Leprosy Patients

About 30 patients affected with Leorosy

Procedure: Measurement of TGF- β1 in leprosy patients

Group B: Healthy People

About 30 Healthy participants

Procedure: Measurement of TGF- β1 in leprosy patients

Interventions

Measurement of TGF- β1 in leprosy patients PROCEDURE

Study TGF- β1gene polymorphism in leprosy patients, and Correlate their results with different types of leprosy before and after treatment.

Group A: Leprosy Patients; Group B: Healthy People

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will include (30) leprosy patients and (30) normal control , selected from the outpatient clinic of the Dermatology, Venereology, and Andrology Department, at Aswan University Hospital.

You may qualify if:

• Patients of both sexes with leprosy.
• Age above 18 years.
• patients on multidrug therapy of leprosy.

You may not qualify if:

• Patients with other dermatological disease.
• Patients with leprosy reaction.
• Pregnancy and lactation.
• Patients with autoimmune disease.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan Universit Hospital

Aswān, Egypt

RECRUITING

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Moustafa Adam Ali El Taieb, Professor

  Dermatology, Venereology and Andrology. Faculty of Medicine, Aswan University

  STUDY CHAIR

• Abdallah Mahmoud Abdallah, Professor

  Biochemistry and Molecular Biology. Faculty of Medicine, Aswan University

  STUDY DIRECTOR

Central Study Contacts

Gehad Adel Abd El-Sabour, M.D

CONTACT

+201000415446; gehada022@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Dermatology

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: July 10, 2024
• Primary Completion: July 5, 2025
• Study Completion: July 10, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-07

Locations

EG (1)