NCT00342004

Brief Summary

A prospective cohort study is proposed to evaluate occupational and environmental risk factors for cancer among women in Shanghai, China. Approximately 75,000 women aged 40-69 who reside in eight geographically defined communities in two urban districts of Shanghai will be recruited via a community-based cancer education program. All eligible subjects will be invited by local health workers from the neighborhood health station to the clinic for an interview and selected anthropometric measurements. The interview will elicit information on demographic background, diet, lifestyle factors, medical history, lifetime occupational history and residential history for the past 20 years. In addition, the women will be asked for information on their husbands' current and usual occupations, and demographic and a few other exposure factors. A spot urine sample and 10 ml of blood will be collected from all cohort members and stored at -70 degrees C for future assays of urine metabolites and DNA and hemoglobin adducts of selected occupational and environmental carcinogens, and polymorphic genes encoding enzymes that are involved in metabolism of relevant carcinogens. Cohort members and their husbands will be followed for cancer outcomes through biennial recontact and linkage with files of the population-based Shanghai Cancer Registry, of the Shanghai Vital Statistics, and of the Shanghai Resident Registry. Medical records and pathology slides will be reviewed for all cancer cases to verify their diagnosis. Post-diagnostic blood samples will be obtained from all cohort members diagnosed with cancer during the follow-up period and stored for future methodologic and etiologic studies. The proposed initial study period is 5 years, with an average follow-up of about 3.5 years. We anticipate, however, that follow-up will continue for 10 years or more.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75,366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

23.3 years

First QC Date

June 19, 2006

Last Update Submit

July 31, 2020

Conditions

Keywords

ShanghaiResidential HistoryExposure AssessmentCohort StudyMolecular Epidemiology

Outcome Measures

Primary Outcomes (1)

  • All cancer incidence

    Any cancer incidence, selected chronic diseases and all causemortality

    up to 30 years

Secondary Outcomes (1)

  • All deaths

    up to 30 years

Study Arms (1)

Healthy Volunteers

Healthy female urban residents in Shanghai between ages of 40-70.

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy female urban residents in Shanghai between ages of 40-70.

You may qualify if:

  • Women aged 40-69 who are permanent residents in eight geographically defined communities of urban Shanghai.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Institute

Shanghai, China

Location

Related Publications (3)

  • Cantor KP, Stewart PA, Brinton LA, Dosemeci M. Occupational exposures and female breast cancer mortality in the United States. J Occup Environ Med. 1995 Mar;37(3):336-48. doi: 10.1097/00043764-199503000-00011.

    PMID: 7796202BACKGROUND
  • Chow WH, Dosemeci M, Zheng W, Vetter R, McLaughlin JK, Gao YT, Blot WJ. Physical activity and occupational risk of colon cancer in Shanghai, China. Int J Epidemiol. 1993 Feb;22(1):23-9. doi: 10.1093/ije/22.1.23.

    PMID: 8449643BACKGROUND
  • Chow WH, Ji BT, Dosemeci M, McLaughlin JK, Gao YT, Fraumeni JF Jr. Biliary tract cancers among textile and other workers in Shanghai, China. Am J Ind Med. 1996 Jul;30(1):36-40. doi: 10.1002/(SICI)1097-0274(199607)30:13.0.CO;2-Q.

    PMID: 8837680BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsLymphoma, Non-HodgkinBreast NeoplasmsStomach NeoplasmsBrain Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Qing Lan, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

May 1, 1997

Primary Completion

July 28, 2020

Study Completion

July 28, 2020

Last Updated

August 4, 2020

Record last verified: 2020-07

Locations