Breast CancerNCT00559039
Effects of Fetal, Infant, and Early Childhood Exposures on Adult Cancer Risk in Women
An observational study of Breast Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- questionnaire administration and evaluation of cancer risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 128,700 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Oct 2006
- 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 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: Fetal, Infant and Early Childhood Antecedents of Cancer in Women: Maternal Cohort Study of the Nurses' Health Studies
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.
Read the 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.
- Being tested
- questionnaire administration, evaluation of cancer risk factors
- Keywords
- breast cancer, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
evaluation of cancer risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of incident cancers and other chronic diseases
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startOct 2000
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 128,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michele R. Forman, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559039
- Sponsor's protocol ID
- 999901015
- Other IDs
- 01-C-N015, CDR0000565931
- Status last verified
- Mar 2012
- First submitted
- 15 Nov 2007
- Last updated
- 8 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal, Infant and Early Childhood Antecedents of Cancer in Women: Maternal Cohort Study of the Nurses' Health Studies
- ClinicalTrials.gov ID
- NCT00559039
- Acronym / sponsor ID
- 999901015
- Keywords
- breast cancer, unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128,700 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2000
- Study completion
- Oct 2006 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Diagnosis of incident cancers and other chronic diseases
Mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele R. Forman, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 8 Mar 2012. 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 United States. 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?
Diagnosis of incident cancers and other chronic diseases. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2012.