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

• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00559039
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 128,700
• Location: 1
• Duration (Months): 72
• Patients Per Site Per Month: 1787.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Other: questionnaire administration; Procedure: evaluation of cancer risk factors

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 128700 participants
• Official Title: Fetal, Infant and Early Childhood Antecedents of Cancer in Women: Maternal Cohort Study of the Nurses' Health Studies
• Study Start Date: Oct 1, 2000
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. Diagnosis of incident cancers and other chronic diseases []

2. Mortality []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland	United States	20892-1182

Sponsors and Collaborators

• National Institutes of Health Clinical Center (CC)
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Michele R. Forman, PhD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00559039
• Other Study ID Numbers: 999901015; 01-C-N015; CDR0000565931; NCT00340145
• First Posted: Nov 16, 2007
• Last Update Posted: Mar 8, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by , ,: breast cancer; unspecified adult solid tumor, protocol specific
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Mar 8, 2012