Clinical trial · Interventional
MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma
Imaging Modalities for Melanoma Screening and Diagnosis
NCT03699995CI-TRIAL-00107578terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study did not meet its accrual goals due to the departure of study personnel. Study team opted for a study closure due to loss of key personnel.
Summary
Brief summary (as posted)
This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Melanocytic Nevus | Nevus | ALIAS | 0.90 |
| Skin Carcinoma | Skin Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal Microscopy | Other | — | UNRESOLVED |
| Dermoscopy | Other | — | UNRESOLVED |
| Imaging Procedure | Procedure | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
| Punch Biopsy | Procedure | — | UNRESOLVED |
| Shave Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (imaging, biopsy)
- description
- Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
- interventionNames
- Other: Confocal Microscopy
- Other: Dermoscopy
- Procedure: Imaging Procedure
- Drug: Lidocaine
- Procedure: Punch Biopsy
- Procedure: Shave Biopsy
Primary outcomes (2)
- measure
- Sensitivity of the imaging modalities
- timeFrame
- Up to 1 year
- description
- Sensitivity is defined as recommend immediate biopsy (red) lesions correctly identified as red by the dermatologists. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Persons who participate in the free skin cancer screening at the PDX Skincare Festival at Oregon Health \& Science University (OHSU) in 2021/2022 (date pending) and are informed by a provider that they have a pigmented lesion for which a biopsy is recommended are potentially eligible to participate in this study. * Persons who participate in the free skin cancer screening at the War on Skin Cancer event at OHSU in 2021/2022 (date pending) or other dates and locations and are informed by a provider that they have a clinically benign or atypical nevi are eligible to participate in the imaging portion of this study. No biopsy will be offered to these participants. * Persons age 18-80 are eligible for the study * Persons of any sex can be enrolled. * Persons of any race are eligible but we anticipate that most participants will be Non-Hispanic whites due to the prevalence of melanoma and other skin cancers in this group. * Only persons who can provide signed statement of informed consent will be enrolled. * Persons who are identified in OHSU Dermatology clinics or through OHSU e-visit and e-consult platforms as having a skin lesion in need of a biopsy for skin cancer * Persons identified via the Melanoma Community Registry (MCR) (IRB approved: 00010561) Exclusion Criteria: * Allergy to the anesthetic (lidocaine).
References
Publications (0)
Data not yet available
No reference posted for this study.