AzTrials
AzTrials

Esophageal CancerNCT00342654

Nutrition Intervention Trials in Linxian Follow-up Study

An observational study of Esophageal Cancer and Gastric Cancer, run by National Cancer Institute (NCI) at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Two large, nutritional intervention trials were conducted in Linxian, China between 1985-1991. These trials tested the effect of multiple vitamins and minerals in the prevention of esophageal cancer in a population with the highest known rate for this disease in the world. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Esophageal Cancer, Gastric Cancer
How many people
32,902 participants
Where
1 siteChina
Study dates
20 May 1999to 2 Dec 2025
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants from two large, nutritional intervention trials that were conducted in Linxian, China between 1985-1991. These trials tested the effect of multiple vitamins and minerals in the prevention of esophageal cancer in a population with the highest known rate for this disease in the world.

  • No eligibility criteria listed.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

Other trials in China

About this study

Official title: Nutritional Intervention Trials in Linxian China- Continued Follow-up

Two large, nutritional intervention trials were conducted in Linxian, China between 1985-1991. These trials tested the effect of multiple vitamins and minerals in the prevention of esophageal cancer in a population with the highest known rate for this disease in the world. Results from the trials showed that Beta-carotene + Vitamin E + selenium reduced total mortality, total cancer mortality, and stomach cancer incidence and mortality. Multivitamins/minerals also showed reduction in premalignant lesions. Preliminary follow-up data obtained for the time period after cessation of intervention in 1991 suggests that the observed benefit for total and cancer mortality is reduced but that the benefit for stomach cancer remains.

The objectives of the follow-up study are: (1) to continue to determine cancer incidence and all causes of mortality in trial participants after intervention to permit examination of potential effects of the interventions on total and cause-specific mortality and cancer incidence in the post-intervention period; (2) to conduct a cross-sectional nutritional survey in a subsample of living trial participants to evaluate their nutritional status, asses the validity of dietary questionnaires, and relate neurologic status to vitamin B12 plasma levels; (3) to collect a blood sample from all living trial participants to permit further etiologic investigations of genetic and environmental hypotheses; and (4) to perform nested case-control studies of selected genetic and environmental hypotheses.

Read more

To accomplish the objectives of the follow-up study, we will: (1) determine updated vital status and cancer status data on all trial participants via monthly checks of village doctor records and quarterly checks of the Linxian Cancer Registry; conduct a Vital/Cancer Status Interview Survey among all (n-34,000 trial participants (or their surrogates); identify, collect, and store all available diagnostic materials for trial participants identified as having developed cancer or died with cancer during the follow-up period; (2) conduct a Nutritional Survey on a subsample (n-1000) of living trial participants that will include (a) a physical exam and brief medical history, (b) a neurologic history, (c) a cognitive function exam, (d) a hair/mouth skin exam, (e) a neurological exam, (f) a nutritional questionnaire, and (g) collection of a blood sample for hematologic/biochemical analyses; (3) conduct a Blood Collection Survey of all living trial participants (n-23,000) to obtain (a) a physical exam and brief medical history and (b) a single 10-ml blood sample for separation and preservation as WBCs (both viable and nonviable), RBCs, and plasma for genetic (e.g., xenobiotic polymorphisms) and environmental (e.g., plasma ascorbic acid) hypothesis testing; and (4) perform Nested Case-Control Studies of selected genetic and environmental hypothesis related to the etiology and prevention of esophageal cancer and stroke. These will be done using serum from the new cancer and stroke cases (-2500) and controls (-2500) previously identified from 1991-1996, as well as using new cancer and stroke cases and controls for the period 1996-2004 (-9000).

The followup for endpoints will continue monthly for an additional 5 years (through the year 2003). The Nutritional Survey and Blood Collection Survey will be conducted in the spring of 1999. The Nested Case-Control studies will be performed annually beginning in 2000, and the Vital/Cancer Interview Survey will be conducted in the Spring of 2001.

Read the detailed description

Two large, nutritional intervention trials were conducted in Linxian, China between 1985-1991. These trials tested the effect of multiple vitamins and minerals in the prevention of esophageal cancer in a population with the highest known rate for this disease in the world. Results from the trials showed that Beta-carotene + Vitamin E + selenium reduced total mortality, total cancer mortality, and stomach cancer incidence and mortality. Multivitamins/minerals also showed reduction in premalignant lesions. Preliminary follow-up data obtained for the time period after cessation of intervention in 1991 suggests that the observed benefit for total and cancer mortality is reduced but that the benefit for stomach cancer remains.

The objectives of the follow-up study are: (1) to continue to determine cancer incidence and all causes of mortality in trial participants after intervention to permit examination of potential effects of the interventions on total and cause-specific mortality and cancer incidence in the post-intervention period; (2) to conduct a cross-sectional nutritional survey in a subsample of living trial participants to evaluate their nutritional status, asses the validity of dietary questionnaires, and relate neurologic status to vitamin B12 plasma levels; (3) to collect a blood sample from all living trial participants to permit further etiologic investigations of genetic and environmental hypotheses; and (4) to perform nested case-control studies of selected genetic and environmental hypotheses.

To accomplish the objectives of the follow-up study, we will: (1) determine updated vital status and cancer status data on all trial participants via monthly checks of village doctor records and quarterly checks of the Linxian Cancer Registry; conduct a Vital/Cancer Status Interview Survey among all (n approximately 34,000 trial participants (or their surrogates); identify, collect, and store all available diagnostic materials for trial participants identified as having developed cancer or died with cancer during the follow-up period; (2) conduct a Nutritional Survey on a subsample (n approximately 1000) of living trial participants that will include (a) a physical exam and brief medical history, (b) a neurologic history, (c) a cognitive function exam, (d) a hair/mouth skin exam, (e) a neurological exam, (f) a nutritional questionnaire, and (g) collection of a blood sample for hematologic/ biochemical analyses; (3) conduct a Blood Collection Survey of all living trial participants (n approximately 23,000) to obtain (a) a physical exam and brief medical history and (b) a single 10-ml blood sample for separation and preservation as WBCs (both viable and nonviable), RBCs, and plasma for genetic (e.g., xenobiotic polymorphisms) and environmental (e.g., plasma ascorbic acid) hypothesis testing; and (4) perform Nested Case-Control Studies of selected genetic and environmental hypothesis related to the etiology and prevention of esophageal cancer and stroke. These will be done using serum from the new cancer and stroke cases (approximately 2500) and controls (approximately 2500) previously identified from 1991-1996, as well as using new cancer and stroke cases and controls for the period 1996-2004 (approximately 9000).

The followup for endpoints will continue monthly for an additional 5 years (through the year 2003). The Nutritional Survey and Blood Collection Survey will be conducted in the spring of 1999. The Nested Case-Control studies will be performed annually beginning in 2000, and the Vital/Cancer Interview Survey will be conducted in the Spring of 2001.

Keywords
Epidemiology, Cancer, Environment, Genetics, Nutrition, Natural History
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00342654
Study groupRoleWhat they receive
1Participants from two large, nutritional intervention trials that were conducted in Linxian, China between 1985-1991.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine cancer incidence and all causes of mortality in trial participants in the post-intervention period and conduct studies ofselected genetic and environmental hypotheses related to the etiology and prevention of esophageal cancer and s...

    analysis is ongoing

    Measured: Ongoing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2006 (estimated)
  2. Study start20 May 1999
  3. Primary completion2 Dec 2025
  4. Study completion2 Dec 2025

Resources

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
Other
Enrolment
32,902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00342654
Sponsor's protocol ID
999999031
Other IDs
OH99-C-N031
Status last verified
22 Sep 2026
First submitted
19 Jun 2006
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Murphy G, Freedman ND, Michel A, Fan JH, Taylor PR, Pawlita M, Qiao YL, Zhang H, Yu K, Abnet CC, Dawsey SM. Prospective study of Helicobacter pylori antigens and gastric noncardia cancer risk in the nutrition intervention trial cohort. Int J Cancer. 2015 Oct 15;137(8):1938-46. doi: 10.1002/ijc.29543. Epub 2015 May 5.

    PubMed 25845708
  • Abnet CC, Freedman ND, Hu N, Wang Z, Yu K, Shu XO, Yuan JM, Zheng W, Dawsey SM, Dong LM, Lee MP, Ding T, Qiao YL, Gao YT, Koh WP, Xiang YB, Tang ZZ, Fan JH, Wang C, Wheeler W, Gail MH, Yeager M, Yuenger J, Hutchinson A, Jacobs KB, Giffen CA, Burdett L, Fraumeni JF Jr, Tucker MA, Chow WH, Goldstein AM, Chanock SJ, Taylor PR. A shared susceptibility locus in PLCE1 at 10q23 for gastric adenocarcinoma and esophageal squamous cell carcinoma. Nat Genet. 2010 Sep;42(9):764-7. doi: 10.1038/ng.649. Epub 2010 Aug 22.

    PubMed 20729852
  • Qiao YL, Dawsey SM, Kamangar F, Fan JH, Abnet CC, Sun XD, Johnson LL, Gail MH, Dong ZW, Yu B, Mark SD, Taylor PR. Total and cancer mortality after supplementation with vitamins and minerals: follow-up of the Linxian General Population Nutrition Intervention Trial. J Natl Cancer Inst. 2009 Apr 1;101(7):507-18. doi: 10.1093/jnci/djp037. Epub 2009 Mar 24.

    PubMed 19318634
  • Yang H, Wang J, Wang X, Sun W, Tong C, Fan J, Qiao Y, Abnet CC. Weight change and all-cause and cause-specific mortality: A 25-year follow-up study. Chin Med J (Engl). 2024 May 20;137(10):1169-1178. doi: 10.1097/CM9.0000000000002970. Epub 2024 Jan 29.

    PubMed 38282387
  • Yang H, Wang JB, Wang XK, Fan JH, Qiao YL. Association between type of drinking water and upper gastrointestinal cancer incidence in the Linxian General Population. BMC Cancer. 2023 May 4;23(1):397. doi: 10.1186/s12885-023-10887-2.

    PubMed 37142988
  • Fan JH, Wang JB, Wang SM, Abnet CC, Qiao YL, Taylor PR. Longitudinal change in blood pressure is associated with cardiovascular disease mortality in a Chinese cohort. Heart. 2018 Nov;104(21):1764-1771. doi: 10.1136/heartjnl-2017-312850. Epub 2018 Apr 24.

    PubMed 29691288
  • Wang SM, Taylor PR, Fan JH, Pfeiffer RM, Gail MH, Liang H, Murphy GA, Dawsey SM, Qiao YL, Abnet CC. Effects of Nutrition Intervention on Total and Cancer Mortality: 25-Year Post-trial Follow-up of the 5.25-Year Linxian Nutrition Intervention Trial. J Natl Cancer Inst. 2018 Nov 1;110(11):1229-1238. doi: 10.1093/jnci/djy043.

    PubMed 29617851
  • Fan JH, Wang JB, Wang SM, Abnet CC, Qiao YL, Taylor PR. Body mass index and risk of gastric cancer: A 30-year follow-up study in the Linxian general population trial cohort. Cancer Sci. 2017 Aug;108(8):1667-1672. doi: 10.1111/cas.13292. Epub 2017 Jun 30.

    PubMed 28594442
  • Chen W, Wang JB, Abnet CC, Dawsey SM, Fan JH, Yin LY, Yin J, Taylor PR, Qiao YL, Freedman ND. Association between C-reactive protein, incident liver cancer, and chronic liver disease mortality in the Linxian Nutrition Intervention Trials: a nested case-control study. Cancer Epidemiol Biomarkers Prev. 2015 Feb;24(2):386-92. doi: 10.1158/1055-9965.EPI-14-1038. Epub 2015 Jan 22.

    PubMed 25613115
  • Wang JB, Abnet CC, Fan JH, Qiao YL, Taylor PR. The randomized Linxian Dysplasia Nutrition Intervention Trial after 26 years of follow-up: no effect of multivitamin supplementation on mortality. JAMA Intern Med. 2013 Jul 8;173(13):1259-61. doi: 10.1001/jamainternmed.2013.6066. No abstract available.

    PubMed 23712839

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer and Gastric Cancer, run by National Cancer Institute (NCI) at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 5 Nov 2026. 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 China. 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?

Determine cancer incidence and all causes of mortality in trial participants in the post-intervention period and conduct studies ofselected genetic and environmental hypotheses related to the etiology and prevention of esophageal cancer and s... (time frame: Ongoing). 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 NCT00342654, which also lists 10 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 5 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in