Effects of Fetal, Infant, and Early Childhood Exposures o... | NCT00559039

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

NCT00559039

Sponsor

National Institutes of Health Clinical Center (CC)

Status

Completed

Last Update Posted

Mar 8, 2012Estimated

Enrollment

128,700Estimated

Phase

Not provided

Conditions

Breast Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Interventions

questionnaire administration
evaluation of cancer risk factors

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2000

Primary Completion Date

Not provided

Completion Date

Oct 2006Actual

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2012

Last Update Posted Date

Mar 8, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

128,700Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of incident cancers and other chronic diseases
Mortality

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele R. Forman, PhD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office		Bethesda	Maryland	20892-1182	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
questionnaire administration	Other
evaluation of cancer risk factors	Procedure

ID	Type	Description	Link
01-C-N015
CDR0000565931