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Effects of Fetal, Infant, and Early Childhood Exposures on Adult Cancer Risk in Women

Primary Purpose

Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
questionnaire administration
evaluation of cancer risk factors
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring breast cancer, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

DISEASE CHARACTERISTICS:

  • Mother of a nurse who is a participant in the Nurses' Health Studies I and II

    • Nurse free of cancer in the year 2000

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

Primary Outcome Measures

Diagnosis of incident cancers and other chronic diseases
Mortality

Secondary Outcome Measures

Full Information

First Posted
November 15, 2007
Last Updated
March 7, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00559039
Brief Title
Effects of Fetal, Infant, and Early Childhood Exposures on Adult Cancer Risk in Women
Official Title
Fetal, Infant and Early Childhood Antecedents of Cancer in Women: Maternal Cohort Study of the Nurses' Health Studies
Study Type
Observational

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Gathering information about pregnancy, infancy, and early childhood exposures may help doctors identify cancer risk factors, and may help the study of cancer. PURPOSE: This natural history study is looking at the effects of fetal, infant, and early childhood exposures on adult cancer risk in women.
Detailed Description
OBJECTIVES: Determine if fetal, infant, and early childhood exposures are associated with adult cancer risk in women. OUTLINE: Mothers of nurses complete questionnaires to collect maternal data, such as pregnancy weight gain, diet during pregnancy, maternal pre-eclampsia, gestational diabetes, gestational age at birth, birth weight, and infant feeding practices. Maternal data is linked to other data collected from critical time periods in the nurses's life cycle, such as menarche, first pregnancy, or adult dietary intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
breast cancer, unspecified adult solid tumor, protocol specific

7. Study Design

Enrollment
128700 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
evaluation of cancer risk factors
Primary Outcome Measure Information:
Title
Diagnosis of incident cancers and other chronic diseases
Title
Mortality

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS: Mother of a nurse who is a participant in the Nurses' Health Studies I and II Nurse free of cancer in the year 2000 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele R. Forman, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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Effects of Fetal, Infant, and Early Childhood Exposures on Adult Cancer Risk in Women

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