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NCT Number: NCT00342992

Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

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).

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Key information

Conditions

Stroke Behavior Brain Diseases Cancer Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Disease Heart Diseases Metabolic Diseases Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases Smoking Vascular Diseases

Age range

50 year–69 year

Sex eligibility

Male

Study type

Observational

Primary location

National Institute of Health and Welfare, Helsinki, Finland

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Cancer

    Time frame: Annually

    Annual linkage with Finnish Cancer Registry

Secondary outcomes

  1. Causes of mortality

    Time frame: Anually

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Collaborators

  • Finnish Institute for Health and Welfare

Registry information

Official study title

Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population

Important dates

Study start
1995
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2006
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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