Kaposi SarcomaNCT03050788
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
A study testing Smartphone confocal microscopy in people with Kaposi Sarcoma, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi Sarcoma
- What is being tested?
- Smartphone confocal microscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteUganda
- Study dates
- 10 Mar 2017to 28 Feb 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in areas which are considered safe to biopsy by the Ugandan providers, which means all areas of the skin except for the mouth and eye.
Who cannot join
- Presence of suspected KS lesions exclusively on the mouth or eye unless clinical specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has proved to be problematic and definitive diagnosis is needed to inform a treatment plan.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.
Read the detailed description
The investigators will perform a cross-sectional study of 500 patients in routine clinical care settings who are suspected to have KS on clinical grounds and for whom skin punch biopsy and histopathological examination is indicated as part of standard of care. Patients will be evaluated with both the gold standard for diagnosis of KS (skin punch biopsy followed by histopathology) and portable confocal microscopy.
- Conditions
- Kaposi Sarcoma
- Being tested
- Smartphone confocal microscopy
- Keywords
- Smartphone confocal microscopy, Kaposi Sarcoma, Point of care diagnosis
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone confocal microscopyDevice
Imaging of skin lesion using the smartphone confocal microscopy
| Study group | Role | What they receive |
|---|---|---|
| Smartphone confocal microscopy imaging | Experimental | Subject's skin lesion will be imaged with the smartphone confocal microscopy. Receives: Device: Smartphone confocal microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy
Confocal microscopy images obtained from the skin lesion will be compared with the corresponding histologic images. Diagnostic accuracy will be tested. No clinical decisions will be made based on confocal microscopy images.
Measured: Approximately 20 minutes (10 minutes for in vivo imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start10 Mar 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Infectious Diseases Institute, Uganda
- Responsible party
- Principal investigator, Dongkyun Kang, Massachusetts General Hospital
- Investigators
- Dongkyun Kang, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050788
- Sponsor's protocol ID
- 2016P002672
- Status last verified
- Oct 2020
- First submitted
- 9 Feb 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT03050788
- Acronym / sponsor ID
- 2016P002672
- Conditions
- Kaposi Sarcoma
- Keywords
- Smartphone confocal microscopy, Kaposi Sarcoma, Point of care diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Infectious Diseases Institute, Uganda
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 13 Feb 2017 (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 investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.
Detailed description
The investigators will perform a cross-sectional study of 500 patients in routine clinical care settings who are suspected to have KS on clinical grounds and for whom skin punch biopsy and histopathological examination is indicated as part of standard of care. Patients will be evaluated with both the gold standard for diagnosis of KS (skin punch biopsy followed by histopathology) and portable confocal microscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone confocal microscopy imaging | Experimental | Device: Smartphone confocal microscopySubject's skin lesion will be imaged with the smartphone confocal microscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in areas which are considered safe to biopsy by the Ugandan providers, which means all areas of the skin except for the mouth and eye.
Key exclusion criteria (1 listed)
- Presence of suspected KS lesions exclusively on the mouth or eye unless clinical specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has proved to be problematic and definitive diagnosis is needed to inform a treatment plan.
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 |
|---|---|---|
| Smartphone confocal microscopyImaging of skin lesion using the smartphone confocal microscopy | Device | Smartphone confocal microscopy imaging |
Primary outcome
Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy
Time frame: Approximately 20 minutes (10 minutes for in vivo imaging)
Confocal microscopy images obtained from the skin lesion will be compared with the corresponding histologic images. Diagnostic accuracy will be tested. No clinical decisions will be made based on confocal microscopy images.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Dongkyun Kang, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone confocal microscopy in people with Kaposi Sarcoma, run by Massachusetts General Hospital at 1 site in Uganda.
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: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy (time frame: Approximately 20 minutes (10 minutes for in vivo imaging)). 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 26 Oct 2020.