Trial Outcomes & Findings for Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi. (NCT NCT00422448)

Results Overview

All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

up to 30 months

Results posted on

2011-01-14

Participant Flow

Pigmented lesion clinic from October 2006 to March 2009

Insufficient prospective accrual of patients during the 1st year of enrollment lead to additional retrospective inclusion of a dataset of 21 paraffin-embedded tissue specimens from excised nevi .

Participant milestones

Participant milestones
Measure	Nevi with or without BRAF and NRAS
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nevi n=43 Participants with or without BRAF and NRAS
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	39.3 years STANDARD_DEVIATION 9.413 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment Austria	22 participants n=5 Participants
Region of Enrollment Italy	21 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 30 months

Population: All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.

All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.

Outcome measures

Outcome measures
Measure	Nevi n=45 nevi with or without BRAF and NRAS
Frequency of BRAF Mutations Among Nevi UDPS (n=24)	19 BRAF mutations
Frequency of BRAF Mutations Among Nevi Sanger method (n=45)	6 BRAF mutations

SECONDARY outcome

Timeframe: 30 months

Population: All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.

All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.

Outcome measures

Outcome measures
Measure	Nevi n=45 number of nevi with or without BRAF and NRAS
Frequency of NRAS Mutations Among Nevi	0 NRAS mutations

Adverse Events

Nevi

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

Prof. Dr. Iris Zalaudek

Medical University of Graz - Austria

Phone: +436763328269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place