Clinical trial · Interventional
The VIDYA Study-designed to Determine if Patients With a History of Basal Cell Carcinoma Are More Inclined to Return for Follow-up if Their Risk of a Subsequent Basal Cell Carcinoma is Quantitated.
An Open-Label, Single Blind Study of How Knowledge of Risk of Subsequent Basal Cell Carcinoma Affects Compliance With Requested Follow-Up in Patients With First Basal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Resources
Summary
Brief summary (as posted)
While current guidelines call for annual follow-up for patients with a history of basal cell carcinoma, compliance with these guidelines is imperfect. It is hypothesized that if patients are informed of the quantitative risk of a subsequent basal cell carcinoma based on individualized risk factors, the compliance rate for follow-up will improve. The primary objective of this study is to assess one-year compliance with requested follow-up for patients with recent history of basal cell carcinoma, among those who receive standard sun avoidance counseling and request for follow-up compared to those who receive, in addition, an estimate of their mathematical risk of a subsequent basal cell carcinoma based on individualized risk factors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| individualized risk assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Subjects will be assigned to the control arm if their subject ID is an odd number. Control arm subjects will not receive counseling for individualized risk assessment for developing a second basal cell carcinoma.
- type
- EXPERIMENTAL
- label
- Individualized risk assessment
- description
- Subjects will be assigned to the intervention arm (i.e., informed of their individualized risk assessment) if their subject ID is an even number. Subjects in the intervention arm will be informed of their estimated 1-year, 3-year, and 5-year risk of developing a second basal cell carcinoma.
- interventionNames
- Other: individualized risk assessment
Primary outcomes (1)
- measure
- Number of participants who have a followup second skin exam by a dermatologist within 1 year of diagnosis of their first basal cell carcinoma (BCC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Diagnosed with at least one Basal Cell Carcinoma within 30 days prior to enrollment * Able and willing to answer all questions accurately in the Individualized Risk Assessment Exclusion Criteria: * History of Basal Cell Carcinoma 31 or more days prior to enrollment * Solid Organ Transplant Recipient * History of Immunodeficiency (e.g., HIV infection, AIDS, genetic immunodeficiency * Prisoner * Psychiatric inpatients or people who are institutionalized
References
Publications (0)
Data not yet available