Trial Outcomes & Findings for Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer (NCT NCT00836342)

Last Updated: 2012-07-25

Results Overview

Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.

Recruitment status

COMPLETED

Target enrollment

81 participants

Primary outcome timeframe

baseline

Results posted on

2012-07-25

Participant Flow

Recruitment occurred from May 2009 to December 2011. Subjects were recruited from dermatology medical and surgery clinics at the Massachusetts General Hospital.

Patients were enrolled in the study if they had a history of cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma but were excluded if they had a history of both basal cell carcinoma and squamous cell carcinoma. Participants were also excluded if they were using retinoids or taking a multivitamin regularly for less than 5 yrs.

Participant milestones

Participant milestones
Measure	Previous History of SCC Participants had previous history of squamous cell carcinoma	Previous History of BCC Participants had previous history of basal cell carcinoma	Control Group Participants had no history of squamous cell carcinoma or basal cell carcinoma
Overall Study STARTED	22	23	36
Overall Study COMPLETED	22	23	36
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Previous History of SCC n=22 Participants Participants had previous history of squamous cell carcinoma	Previous History of BCC n=23 Participants Participants had previous history of basal cell carcinoma	Control Group n=36 Participants Participants had no history of squamous cell carcinoma or basal cell carcinoma	Total n=81 Participants Total of all reporting groups
Age Continuous Mean age	63.9 years n=5 Participants	60.9 years n=7 Participants	57.4 years n=5 Participants	60.2 years n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	23 Participants n=7 Participants	31 Participants n=5 Participants	76 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline

Population: Participants that passed inclusion criteria and consented for skin carotenoid measurement were analyzed.

Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.

Outcome measures

Outcome measures
Measure	Previous History of SCC n=22 Participants Participants had previous history of squamous cell carcinoma	Control Group n=36 Participants Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects	27,635 Raman spectroscopy intensity counts Standard Deviation 12,013	31,219 Raman spectroscopy intensity counts Standard Deviation 13,320

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Previous History of SCC n=22 Participants Participants had previous history of squamous cell carcinoma	Control Group n=23 Participants Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma	27,635 Raman spectroscopy intensity counts Standard Deviation 12,013	25,031 Raman spectroscopy intensity counts Standard Deviation 12,825

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Previous History of SCC n=23 Participants Participants had previous history of squamous cell carcinoma	Control Group n=36 Participants Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group	25,031 Raman spectrocopy intensity counts Standard Deviation 12,825	31,219 Raman spectrocopy intensity counts Standard Deviation 13,320

Adverse Events

Previous History of SCC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Previous History of BCC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Kristen Corey

Clinical Unit for Research Trials in Skin, Massachusetts General Hospital

Phone: 617-726-1302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place