MycetomaNCT06512714
Mycetoma Retrospective Data Collection
An observational study of Mycetoma, run by Drugs for Neglected Diseases at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycetoma
- What is being tested?
- A diagnosis of mycetoma in a medical, radiologic, or laboratory record.
- How many people
- 1,600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jun 2024to 31 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
Who may be able to join
- Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
Who cannot join
- Patients with illegible or inaccessible health records.
Trial locations and contacts
2 sites in 2 countries.
Thaddaeus W Egondi, Dr. contact
2 sites in 2 countries
India1 site, 1 recruiting
- Not yet recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
Shivaprakash M Rudramurthy, M.D, +9316175146
Senegal1 site, 1 recruiting
- Recruiting
Universite Cheikh Anta Diop de Dakar
Dakar
Doudou Sow, PhD, +221775425028, doudou.sow@ugb.edu.sn
Babacar T Faye, babacarfaye626@gmail.com
About this study
Official title: Estimating the Burden of Mycetoma: A Retrospective Analysis of Hospital Records
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.
Read more
- Describe demographic characteristics of patients with mycetoma.
- Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.
- Assess etiology of mycetoma cases.
- Characterize clinical management of mycetoma cases.
- Characterize approaches to diagnosis of mycetoma.
- Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.
- 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.
Read the detailed description
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.
- Conditions
- Mycetoma
- Being tested
- A diagnosis of mycetoma in a medical, radiologic, or laboratory record.
- Medical subject headings
- Mycetoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A diagnosis of mycetoma in a medical, radiologic, or laboratory record.Other
For 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of mycetoma disease as evidenced by patient diagnosis
Sources: Medical records and/or laboratory records and/or radiologic records.
Measured: Over 10 years
Secondary outcomes (2)
Lesion size in centimeters
Sources: Medical records and laboratory records
Measured: Over 10 years
Presence of mycetoma disease after treatment or surgery
Sources: Medical records and laboratory records
Measured: Over 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start20 Jun 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MycetomaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Cheikh Anta Diop University, Senegal, Post Graduate Institute of Medical Education and Research, Chandigarh
- Responsible party
- Sponsor
- Investigators
- Doudou Sow, PhD, Principal investigator, Université Gaston BergerShivaprakash M Rudramurthy, M.D, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512714
- Sponsor's protocol ID
- DNDi-OBS-03-MYC
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi, de-identified or aggregated data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Burden of Mycetoma: A Retrospective Analysis of Hospital Records
- ClinicalTrials.gov ID
- NCT06512714
- Acronym / sponsor ID
- DNDi-OBS-03-MYC
- Conditions
- Mycetoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Cheikh Anta Diop University, Senegal, Post Graduate Institute of Medical Education and Research, Chandigarh
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
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.
- Describe demographic characteristics of patients with mycetoma.
- Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.
- Assess etiology of mycetoma cases.
- Characterize clinical management of mycetoma cases.
- Characterize approaches to diagnosis of mycetoma.
- Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.
- 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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
Key inclusion criteria (1 listed)
- Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
Key exclusion criteria (1 listed)
- Patients with illegible or inaccessible health records.
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 |
|---|---|---|
| A diagnosis of mycetoma in a medical, radiologic, or laboratory record.For 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. | Other | – |
Primary outcome
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.
2 secondary outcomes
Lesion size in centimeters
Time frame: Over 10 years
Presence of mycetoma disease after treatment or surgery
Time frame: Over 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Yes. Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi, de-identified or aggregated data will be shared
Related trials for Mycetoma
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
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.
Thaddaeus W Egondi, Dr. contact
Doudou Sow, PhD principal investigator
Université Gaston Berger
Shivaprakash M Rudramurthy, M.D principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycetoma, run by Drugs for Neglected Diseases at 2 sites in 2 countries.
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 1 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Borna A Nyaoke, M.D (+254 203995031, bnyaoke@dndi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of mycetoma disease as evidenced by patient diagnosis (time frame: Over 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.