StrokeNCT00342992
Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study
An observational study of Stroke and Diabetes Mellitus, run by National Cancer Institute (NCI) at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 69 years, men only
- Conditions the study is for
- Stroke, Diabetes Mellitus, Heart Disease
- How many people
- 29,133 participants
- Where
- 1 siteFinland
- Study dates
- 3 Mar 1995to 4 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male smokers in Southwestern Finland
Who may be able to join
- Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
National Institute of Health and Welfare, Helsinki, Finland
Helsinki
About this study
Official title: Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population
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).
Read the 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.
- Conditions
- Stroke, Diabetes Mellitus, Heart Disease, Cancer
- Keywords
- Vitamin E, Micronutrients, Genetics, Smoking, Biomarkers
- Medical subject headings
- Stroke, Diabetes Mellitus, Heart Diseases, Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Male smokers in Southwestern Finland |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer
Annual linkage with Finnish Cancer Registry
Measured: Annually
Secondary outcomes (1)
Causes of mortality
Measured: Anually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start3 Mar 1995
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Finnish Institute for Health and Welfare
- Responsible party
- Sponsor
- Investigators
- Demetrius A Albanes, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342992
- Sponsor's protocol ID
- 999995012
- Other IDs
- OH95-C-N012
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2006
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
The alpha-tocopherol, beta-carotene lung cancer prevention study: design, methods, participant characteristics, and compliance. The ATBC Cancer Prevention Study Group. Ann Epidemiol. 1994 Jan;4(1):1-10. doi: 10.1016/1047-2797(94)90036-1.
PubMed 8205268Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994 Apr 14;330(15):1029-35. doi: 10.1056/NEJM199404143301501.
PubMed 8127329Heinonen OP, Albanes D, Virtamo J, Taylor PR, Huttunen JK, Hartman AM, Haapakoski J, Malila N, Rautalahti M, Ripatti S, Maenpaa H, Teerenhovi L, Koss L, Virolainen M, Edwards BK. Prostate cancer and supplementation with alpha-tocopherol and beta-carotene: incidence and mortality in a controlled trial. J Natl Cancer Inst. 1998 Mar 18;90(6):440-6. doi: 10.1093/jnci/90.6.440.
PubMed 9521168Zhang T, Moore SC, Fu S, Albanes D, Liao LM, Loftfield E, Playdon MC, Weinstein SJ, Yu K, Stolzenberg-Solomon RZ. Metabolomic profiling of genotype-derived ABO blood group, secretor status, and Lewis antigens and association with pancreatic ductal adenocarcinoma risk. Am J Epidemiol. 2026 Jun 3;195(6):1572-1584. doi: 10.1093/aje/kwag055.
PubMed 41804787Etievant L, Gail MH, Albanes D. Disentangling discordant vitamin D associations with prostate cancer incidence and fatality in a large, nested case-control study. Int J Epidemiol. 2024 Aug 14;53(5):dyae110. doi: 10.1093/ije/dyae110.
PubMed 39180769Huang J, Hodis HN, Weinstein SJ, Mack WJ, Sampson JN, Mondul AM, Albanes D. Serum Metabolomic Response to Low- and High-Dose Vitamin E Supplementation in Two Randomized Controlled Trials. Cancer Epidemiol Biomarkers Prev. 2020 Jul;29(7):1329-1334. doi: 10.1158/1055-9965.EPI-20-0187. Epub 2020 Apr 20.
PubMed 32312759Hemila H. Vitamin E and Mortality in Male Smokers of the ATBC Study: Implications for Nutritional Recommendations. Front Nutr. 2020 Mar 31;7:36. doi: 10.3389/fnut.2020.00036. eCollection 2020.
PubMed 32296711Hemila H. The effect of beta-carotene on the mortality of male smokers is modified by smoking and by vitamins C and E: evidence against a uniform effect of nutrient. J Nutr Sci. 2020 Mar 11;9:e11. doi: 10.1017/jns.2020.3.
PubMed 32215208Lai GY, Wang JB, Weinstein SJ, Parisi D, Horst RL, McGlynn KA, Mannisto S, Albanes D, Freedman ND. Association of 25-Hydroxyvitamin D with Liver Cancer Incidence and Chronic Liver Disease Mortality in Finnish Male Smokers of the ATBC Study. Cancer Epidemiol Biomarkers Prev. 2018 Sep;27(9):1075-1082. doi: 10.1158/1055-9965.EPI-17-0877. Epub 2018 May 2.
PubMed 29720370Playdon MC, Moore SC, Derkach A, Reedy J, Subar AF, Sampson JN, Albanes D, Gu F, Kontto J, Lassale C, Liao LM, Mannisto S, Mondul AM, Weinstein SJ, Irwin ML, Mayne ST, Stolzenberg-Solomon R. Identifying biomarkers of dietary patterns by using metabolomics. Am J Clin Nutr. 2017 Feb;105(2):450-465. doi: 10.3945/ajcn.116.144501. Epub 2016 Dec 28.
PubMed 28031192Miranti EH, Freedman ND, Weinstein SJ, Abnet CC, Selhub J, Murphy G, Diaw L, Mannisto S, Taylor PR, Albanes D, Stolzenberg-Solomon RZ. Prospective study of serum cysteine and cysteinylglycine and cancer of the head and neck, esophagus, and stomach in a cohort of male smokers. Am J Clin Nutr. 2016 Sep;104(3):686-93. doi: 10.3945/ajcn.115.125799. Epub 2016 Aug 17.
PubMed 27534643Lai GY, Weinstein SJ, Taylor PR, McGlynn KA, Virtamo J, Gail MH, Albanes D, Freedman ND. Effects of alpha-tocopherol and beta-carotene supplementation on liver cancer incidence and chronic liver disease mortality in the ATBC study. Br J Cancer. 2014 Dec 9;111(12):2220-3. doi: 10.1038/bjc.2014.514. Epub 2014 Oct 14.
PubMed 25314069Moy KA, Mondul AM, Zhang H, Weinstein SJ, Wheeler W, Chung CC, Mannisto S, Yu K, Chanock SJ, Albanes D. Genome-wide association study of circulating vitamin D-binding protein. Am J Clin Nutr. 2014 Jun;99(6):1424-31. doi: 10.3945/ajcn.113.080309. Epub 2014 Apr 16.
PubMed 24740207Mondul AM, Sampson JN, Moore SC, Weinstein SJ, Evans AM, Karoly ED, Virtamo J, Albanes D. Metabolomic profile of response to supplementation with beta-carotene in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Am J Clin Nutr. 2013 Aug;98(2):488-93. doi: 10.3945/ajcn.113.062778. Epub 2013 Jun 26.
PubMed 23803886Major JM, Yu K, Chung CC, Weinstein SJ, Yeager M, Wheeler W, Snyder K, Wright ME, Virtamo J, Chanock S, Albanes D. Genome-wide association study identifies three common variants associated with serologic response to vitamin E supplementation in men. J Nutr. 2012 May;142(5):866-71. doi: 10.3945/jn.111.156349. Epub 2012 Mar 21.
PubMed 22437554
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population
- ClinicalTrials.gov ID
- NCT00342992
- Acronym / sponsor ID
- 999995012
- Conditions
- Stroke, Diabetes Mellitus, Heart Disease, Cancer
- Keywords
- Vitamin E, Micronutrients, Genetics, Smoking, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29,133 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Finnish Institute for Health and Welfare
- Study start
- 3 Mar 1995 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Male smokers in Southwestern Finland |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male smokers in Southwestern Finland
Key inclusion criteria (1 listed)
- Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.
Key exclusion criteria (8 listed)
- Females
- Proven malignancy (except nonmelanoma skin cancer or cancer in situ)
- Severe angina pectoris
- Chronic renal insufficiency
- Cirrhosis of the liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer
Time frame: Annually
Annual linkage with Finnish Cancer Registry
1 secondary outcome
Causes of mortality
Time frame: Anually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 8205268The alpha-tocopherol, beta-carotene lung cancer prevention study: design, methods, participant characteristics, and compliance. The ATBC Cancer Prevention Study Group. Ann Epidemiol. 1994 Jan;4(1):1-10. doi: 10.1016/1047-2797(94)90036-1.
- Background: PubMed 8127329Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994 Apr 14;330(15):1029-35. doi: 10.1056/NEJM199404143301501.
- Background: PubMed 9521168Heinonen OP, Albanes D, Virtamo J, Taylor PR, Huttunen JK, Hartman AM, Haapakoski J, Malila N, Rautalahti M, Ripatti S, Maenpaa H, Teerenhovi L, Koss L, Virolainen M, Edwards BK. Prostate cancer and supplementation with alpha-tocopherol and beta-carotene: incidence and mortality in a controlled trial. J Natl Cancer Inst. 1998 Mar 18;90(6):440-6. doi: 10.1093/jnci/90.6.440.
- Derived from this study: PubMed 41804787Zhang T, Moore SC, Fu S, Albanes D, Liao LM, Loftfield E, Playdon MC, Weinstein SJ, Yu K, Stolzenberg-Solomon RZ. Metabolomic profiling of genotype-derived ABO blood group, secretor status, and Lewis antigens and association with pancreatic ductal adenocarcinoma risk. Am J Epidemiol. 2026 Jun 3;195(6):1572-1584. doi: 10.1093/aje/kwag055.
- Derived from this study: PubMed 39180769Etievant L, Gail MH, Albanes D. Disentangling discordant vitamin D associations with prostate cancer incidence and fatality in a large, nested case-control study. Int J Epidemiol. 2024 Aug 14;53(5):dyae110. doi: 10.1093/ije/dyae110.
- Derived from this study: PubMed 32312759Huang J, Hodis HN, Weinstein SJ, Mack WJ, Sampson JN, Mondul AM, Albanes D. Serum Metabolomic Response to Low- and High-Dose Vitamin E Supplementation in Two Randomized Controlled Trials. Cancer Epidemiol Biomarkers Prev. 2020 Jul;29(7):1329-1334. doi: 10.1158/1055-9965.EPI-20-0187. Epub 2020 Apr 20.
- Derived from this study: PubMed 32296711Hemila H. Vitamin E and Mortality in Male Smokers of the ATBC Study: Implications for Nutritional Recommendations. Front Nutr. 2020 Mar 31;7:36. doi: 10.3389/fnut.2020.00036. eCollection 2020.
- Derived from this study: PubMed 32215208Hemila H. The effect of beta-carotene on the mortality of male smokers is modified by smoking and by vitamins C and E: evidence against a uniform effect of nutrient. J Nutr Sci. 2020 Mar 11;9:e11. doi: 10.1017/jns.2020.3.
- Derived from this study: PubMed 29720370Lai GY, Wang JB, Weinstein SJ, Parisi D, Horst RL, McGlynn KA, Mannisto S, Albanes D, Freedman ND. Association of 25-Hydroxyvitamin D with Liver Cancer Incidence and Chronic Liver Disease Mortality in Finnish Male Smokers of the ATBC Study. Cancer Epidemiol Biomarkers Prev. 2018 Sep;27(9):1075-1082. doi: 10.1158/1055-9965.EPI-17-0877. Epub 2018 May 2.
- Derived from this study: PubMed 28031192Playdon MC, Moore SC, Derkach A, Reedy J, Subar AF, Sampson JN, Albanes D, Gu F, Kontto J, Lassale C, Liao LM, Mannisto S, Mondul AM, Weinstein SJ, Irwin ML, Mayne ST, Stolzenberg-Solomon R. Identifying biomarkers of dietary patterns by using metabolomics. Am J Clin Nutr. 2017 Feb;105(2):450-465. doi: 10.3945/ajcn.116.144501. Epub 2016 Dec 28.
- Derived from this study: PubMed 27534643Miranti EH, Freedman ND, Weinstein SJ, Abnet CC, Selhub J, Murphy G, Diaw L, Mannisto S, Taylor PR, Albanes D, Stolzenberg-Solomon RZ. Prospective study of serum cysteine and cysteinylglycine and cancer of the head and neck, esophagus, and stomach in a cohort of male smokers. Am J Clin Nutr. 2016 Sep;104(3):686-93. doi: 10.3945/ajcn.115.125799. Epub 2016 Aug 17.
- Derived from this study: PubMed 25314069Lai GY, Weinstein SJ, Taylor PR, McGlynn KA, Virtamo J, Gail MH, Albanes D, Freedman ND. Effects of alpha-tocopherol and beta-carotene supplementation on liver cancer incidence and chronic liver disease mortality in the ATBC study. Br J Cancer. 2014 Dec 9;111(12):2220-3. doi: 10.1038/bjc.2014.514. Epub 2014 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetrius A Albanes, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Diabetes Mellitus, run by National Cancer Institute (NCI) at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer (time frame: Annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342992, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.