A diagnosis of mycetoma in a medical, radiologic, or laboratory record.
OtherFor each patient, data will be extracted for each clinical, laboratory or radiologic visit related to the condition that may meet this study's case definition.
Recruiting
NCT Number: NCT06512714
Mycetoma Retrospective Data Collection
The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period. The main objectives are to:
* Determine the number of mycetoma cases diagnosed per year and trends over time. * Describe characteristics of diagnosed mycetoma cases.
1. Describe demographic characteristics of patients with mycetoma. 2. Describe clinical characteristics of patients with mycetoma upon initial presentation and over time. * Assess etiology of mycetoma cases. * Characterize clinical management of mycetoma cases.
1. Characterize approaches to diagnosis of mycetoma. 2. Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases. 3. Describe clinical outcomes among patients with mycetoma.
The study team will review all available medical, laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Postgraduate Institute of Medical Education and Research, Chandigarh, India
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About this study
Mycetoma is a poorly understood neglected tropical disease which disproportionately affects the poorest of the poor and is associated with substantial morbidity. The disease presents a multitude of diagnostic and management challenges; in particular, effective treatments for eumycetoma, the fungal and least understood form of the disease are lacking. DNDi and partners aim to conduct late-phase clinical trials on a promising new pharmacologic treatment for eumycetoma, but substantial knowledge gaps preclude such trials. These knowledge gaps include data on the burden, distribution, causative agents, clinical presentation, natural history, and common approaches to diagnosis and treatment of mycetoma in endemic countries.
This study, a retrospective review of mycetoma cases, aims to generate such data from several countries suggested by preliminary data to potentially be good candidate clinical trial sites.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
Exclusion criteria
- Patients with illegible or inaccessible health records.
Treatment and study plan
Primary outcomes
-
Presence of mycetoma disease as evidenced by patient diagnosis
Time frame: Over 10 years
Sources: Medical records and/or laboratory records and/or radiologic records.
Secondary outcomes
-
Lesion size in centimeters
Time frame: Over 10 years
Sources: Medical records and laboratory records
-
Presence of mycetoma disease after treatment or surgery
Time frame: Over 10 years
Sources: Medical records and laboratory records
Study contacts
Contact information is provided by the study sponsor or research team.
Borna A Nyaoke, M.D
CONTACT
Thaddaeus W Egondi, Dr.
CONTACT
Sponsors and collaborators
Lead sponsor
Drugs for Neglected Diseases
Other
Collaborators
- Cheikh Anta Diop University, Senegal
- Post Graduate Institute of Medical Education and Research, Chandigarh
Registry information
Official study title
Estimating the Burden of Mycetoma: A Retrospective Analysis of Hospital Records
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Jul 22, 2024
- Registry last updated
- Aug 1, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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