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.

NCT04093401 | Withdrawn DMC

• 4 other identifiers: UW190022019-0077A534300SMPH/DERMATOLOGY/DERMATOLOG
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  up to 13 months

Secondary Outcomes (2)

• Frequency of sunscreen use when out in sun

  up to 13 months

• Frequency of sunburns within the past year

  up to 13 months

Study Arms (2)

Control

NO INTERVENTION

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.

Individualized risk assessment

EXPERIMENTAL

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.

Other: individualized risk assessment

Interventions

individualized risk assessment OTHER

Individualized risk assessment of developing a second basal cell carcinoma

Individualized risk assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Robert J Glinert, MD

  clinical professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share