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The impact of a SmartPhone applicatiOn for skin cancer risk assessmenT on the healthcare system (SPOT-study): A randomized controlled trial.

The impact of a SmartPhone applicatiOn for skin cancer risk assessmenT on the healthcare system (SPOT-study): A randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24380
Enrollment
200000
Registered
2021-07-01
Start date
2021-08-04
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premalignant skin lesions, skin malignancies (including: melanomas, basal cell carcinomas, cutaneous squamous cell carcinomas and rare skin cancers) and benign skin tumors.

Interventions

The intervention group will be offered to use the SkinVision app for free, for a duration of one year. After this year the control group will receive access to the SVA for the period of one year. Both

Sponsors

Department of Dermatology, Erasmus MC Cancer Institute Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following inclusion criteria: - Ability to give informed consent for this study. - = 18 years old. - Receive health care insurance from DSW.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Persons without an email address. - Persons without a (compatible) smartphone. - Persons without an internet connection.

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the difference in skin tumor related care between the intervention group and the control group during 12 months, which is assessed by comparison of: - The incidence of malignant skin tumors in Palga (national pathology database). - The incidence of claims for benign skin tumors. - The incidence of claims for (pre)malignant skin tumors.

Secondary

MeasureTime frame
The secondary outcomes have been defined as: - The cost-effectiveness of the SVA, which will be measured by the costs per detected skin cancer. - The impact of SVA usage on primary care, which will be measures by surgical claims in primary care, although rather general coding will be a limiting factor. - Comparison of the proportion of dermatological care received between the intervention group and the control group: Dermatological care will be specified for new dermatology consultations, follow-up visits, performed biopsies and excisions. - The proportion of false negative melanomas within 2 years after using the SVA based on linkage with Palga.

Contacts

Public ContactMarlies Wakkee

Erasmus MC

m.wakkee@erasmusmc.nl+31107040110

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)