Trial Outcomes & Findings for Study of Lung Cancer in Appalachian Kentucky: The Role of Environmental Carcinogens (NCT NCT01648166)

Results Overview

Conduct a case-control study of lung cancer and matched controls in the 5th Congressional District of Kentucky to compare rates of moderate to high arsenic in lung cancer cases and controls (primary endpoint).

Recruitment status

COMPLETED

Target enrollment

520 participants

Primary outcome timeframe

up to three years

Results posted on

2019-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Lung Cancer Cases subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia	Control Subjects subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia
Overall Study STARTED	153	367
Overall Study COMPLETED	100	267
Overall Study NOT COMPLETED	53	100

Reasons for withdrawal

Reasons for withdrawal
Measure	Lung Cancer Cases subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia	Control Subjects subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia
Overall Study inadequate toenail samples	53	100

Baseline Characteristics

only those with adequate toenails could complete the primary outcome measure of arsenic in nail.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lung Cancer Cases n=100 Participants subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia	Control Subjects n=267 Participants subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia	Total n=367 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants • only those with adequate toenails could complete the primary outcome measure of arsenic in nail.	148 Participants n=7 Participants • only those with adequate toenails could complete the primary outcome measure of arsenic in nail.	209 Participants n=5 Participants • only those with adequate toenails could complete the primary outcome measure of arsenic in nail.
Sex: Female, Male Male	39 Participants n=5 Participants • only those with adequate toenails could complete the primary outcome measure of arsenic in nail.	119 Participants n=7 Participants • only those with adequate toenails could complete the primary outcome measure of arsenic in nail.	158 Participants n=5 Participants • only those with adequate toenails could complete the primary outcome measure of arsenic in nail.
Region of Enrollment United States	100 participants n=5 Participants	267 participants n=7 Participants	367 participants n=5 Participants

PRIMARY outcome

Timeframe: up to three years

Population: those with adequate toenail arsenic concentrations

Conduct a case-control study of lung cancer and matched controls in the 5th Congressional District of Kentucky to compare rates of moderate to high arsenic in lung cancer cases and controls (primary endpoint).

Outcome measures

Outcome measures
Measure	Lung Cancer Cases n=100 Participants subjects with lung cancer who are greater than 17 years of age and live in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia	Control Subjects n=267 Participants subjects without lung cancer, greater than 17 who reside in Appalachian Kentucky Environmental sampling: Soil, water, blood, urine, hair and radon testing in homes in Appalachia
Rate of Moderate to High Arsenic Level in Cases and Controls	0.04 mcg/dL Interval 0.03 to 0.06	0.04 mcg/dL Interval 0.02 to 0.07

Adverse Events

Lung Cancer Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Subjects

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

Dr. Susanne Arnold

University of Kentucky

Phone: 8592579568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place