Tissue Microenvironment Signatures of the Mycetoma Granuloma

NCT04401969 | Completed

• 1 other identifier: Mycetoma Study
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Mycetoma is the most neglected of the neglected tropical diseases. It is caused by certain fungi or bacteria. It is endemic in many tropical and subtropical regions and Sudan seems to be the mycetoma homeland. This chronic subcutaneous destructive and disabling inflammatory disease has many serious medical and socio-economic impacts on patients, community and health authorities. This work may suggest new therapeutic options for mycetoma that target the inflammatory pathogenic pathway and hence help in designing universal treatment options for mycetoma patients. Two overlapping aims were investigated in this project to advance our overall goals:

1. 1.Profiling the immune/inflammatory signatures in the tissue microenvironment of fungus-induced mycetoma lesions
2. 2.Profiling the immune/inflammatory signatures in the tissue microenvironment of bacteria-induced mycetoma lesions.

Conditions

Mycetoma

Outcome Measures

Primary Outcomes (2)

• immune cell phenotypes

  detection of immune cell phenotypes in mycetoma lesions

  24 months

• antigen-specific t-cell responses

  detection of t cell and myeloid cell phenotype in peripheral blood

  24 months

Study Arms (3)

Patients with eumycetoma lesions

Patients with eumycetoma lesions

Patients with actinomycetoma lesions

Patients with actinomycetoma lesions

Patients with lesions of unknown causality

Patients with lesions of unknown causality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited from Soba University Hospital Mycetoma clinic 10 patients with eumycetoma lesions 12 patients with actinomycetoma lesions 6 patients with lesions of unknown causality

You may qualify if:

• Patients aged over 18 years with either small or advanced eumycetoma lesions with either small or advanced actinmycetoma lesions with lesions of unknown causality

You may not qualify if:

• \<18 years of age Inability to provide informed consent Any other reason that in the opinion of the Investigator indicates the subject cannot comply with study protocol

Sponsors & Collaborators

• University of Khartoum: lead
• University of York: collaborator

Study Sites (1)

University Hospital Soba

Khartoum, 1111, Sudan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Needle biopsy samples from mycetoma lesions Fine needle aspirates from the matching mycetoma lesion Whole blood for RNA analysis

MeSH Terms

Conditions

Mycetoma

Condition Hierarchy (Ancestors)

Nocardia Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Dermatomycoses; Mycoses; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mohamed Osman, PhD

  University of Khartoum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 26, 2020
• Study Start: March 7, 2019
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)