Trial Outcomes & Findings for The Impact of Total Body Skin Examination on Skin Cancer Detection (NCT NCT00765193)

NCT ID: NCT00765193

Last Updated: 2010-04-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14381 participants
• Primary outcome timeframe: one year
• Results posted on: 2010-04-15

Participant Flow

Participant milestones

Measure	Skin Cancer Screening Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
Problem Area Examination STARTED	14381
Problem Area Examination COMPLETED	14381
Problem Area Examination NOT COMPLETED	0
Full Body Examination STARTED	14381
Full Body Examination COMPLETED	14381
Full Body Examination NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Total Body Skin Examination on Skin Cancer Detection

Baseline characteristics by cohort

Measure	Skin Cancer Screening n=14381 Participants Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11027 Participants n=5 Participants
Age, Categorical >=65 years	3354 Participants n=5 Participants
Age Continuous	49.4 years STANDARD_DEVIATION 18.4 • n=5 Participants
Sex: Female, Male Female	7984 Participants n=5 Participants
Sex: Female, Male Male	6397 Participants n=5 Participants
Region of Enrollment Austria	997 participants n=5 Participants
Region of Enrollment Italy	7381 participants n=5 Participants
Region of Enrollment Brazil	2010 participants n=5 Participants
Region of Enrollment France	999 participants n=5 Participants
Region of Enrollment Argentina	1001 participants n=5 Participants
Region of Enrollment Netherlands	787 participants n=5 Participants
Region of Enrollment Spain	179 participants n=5 Participants
Region of Enrollment Turkey	984 participants n=5 Participants
Region of Enrollment Australia	43 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: From a population of patients with various skin conditions, participants were considered for inclusion only if aged 18 years or more, and if suffering from focused skin complaints. Patients with diffuse skin complaints were excluded.

Outcome measures

Measure	Problem Area Examination n=14381 Participants	Full Body Examination n=14381 Participants
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.	810 participants	631 participants

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

Adverse Events

Skin Cancer Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Iris Zalaudek, MD

Department of Dermatology, Medical University of Graz-Austria

Phone: +436763328269

Email: iris.zalaudek@medunigraz.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place