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Trial record 1 of 1 for:    Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC)
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Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00342992
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Finnish Institute for Health and Welfare
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

The project is a passive follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort. Originally, this was a large, randomized, double-blind, placebo-controlled, 2x2 factorial primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. The study was conducted in Finland as a collaboration between the U.S. National Cancer Institute (NCI) and the National Public Health Institute of Finland. NCI has maintained passive surveillance of the cohort through Finnish national registries, including the cancer registry.

The primary purpose of the ATBC cohort follow-up is to use the existing risk factor data and biological specimens (i.e., serum, whole blood, DNA, red blood cells, and toenails) to test hypotheses relevant to cancer etiology, survival, early detection, and prevention. These data and biospecimens continue to provide an invaluable resource for the study of biochemical, nutritional, genetic, and molecular hypotheses. These analyses are made all the more informative and powerful by the addition of cases identified annually during the follow-up period, and the research benefits from a longer pre-diagnosis period (now over 30 years).


Condition or disease
Stroke Diabetes Mellitus Heart Disease Cancer

Detailed Description:
The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, beta-carotene, or both would reduce the incidence of lung or other cancers among male smokers. Between 1985 and 1988, 29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited from southwestern Finland. Participants were randomly assigned to receive either a-tocopherol as dl-a-tocopheryl acetate (50 mg/day), beta-carotene as all-trans-beta-carotene (20 mg/day), both supplements, or placebo capsules for 5-8 years (median 6.1 years) through April 30, 1993. Post-intervention follow-up has continued through the Finnish Cancer Registry and other national registries, and epidemiological analyses continue to be conducted.

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Study Type : Observational
Actual Enrollment : 29133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population
Actual Study Start Date : March 3, 1995
Actual Primary Completion Date : September 4, 2020
Actual Study Completion Date : September 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Group/Cohort
Healthy Volunteers
Male smokers in Southwestern Finland



Primary Outcome Measures :
  1. Cancer [ Time Frame: Annually ]
    Annual linkage with Finnish Cancer Registry


Secondary Outcome Measures :
  1. Causes of mortality [ Time Frame: Anually ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male smokers in Southwestern Finland
Criteria
  • INCLUSION CRITERIA:

Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.

EXCLUSION CRITERIA:

  • Females
  • Proven malignancy (except nonmelanoma skin cancer or cancer in situ)
  • Severe angina pectoris
  • Chronic renal insufficiency
  • Cirrhosis of the liver
  • Chronic alcoholism
  • Anticoagulant therapy
  • Use of supplements containing vitamin E greater than 20 mg/day, or vitaming A greater than 20,000 IU/day, or beta-carotene greater than 6 mg/day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342992


Locations
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Finland
National Institute of Health and Welfare, Helsinki, Finland
Helsinki, Finland
Sponsors and Collaborators
National Cancer Institute (NCI)
Finnish Institute for Health and Welfare
Investigators
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Principal Investigator: Demetrius A Albanes, M.D. National Cancer Institute (NCI)
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00342992    
Other Study ID Numbers: 999995012
OH95-C-N012
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Vitamin E
Micronutrients
Genetics
Smoking
Biomarkers
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases