- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253666
Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study population consisted of two ongoing cohorts: the Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS). The NHS began in 1976 when 121,700 female nurses aged 33-55 years and residing in the United States responded to a baseline questionnaire. The HPFS began in 1986 when 51,529 male health professionals aged 40-75 years and residing in the United States completed a similar baseline questionnaire. Study investigators sent follow-up questionnaires biennially to participants to update information on past medical history as well as lifestyle factors.
Follow up was started in 1984 for the NHS and 1986 for the HPFS when diet was measured with an expanded food frequency questionnaire (FFQ). Participants in the NHS responded to an ~130 item semi-quantitative FFQ in 1984, 1986, and then every four years thereafter, while those in the HPFS responded to a similar FFQ in 1986 and then every four years thereafter. The FFQ collected information on average intake of each food item over the past year. It also specified a common serving size for each item. Participants could select from one of nine intake frequency choices, ranging from less than once per month to six or more times per day. Participants also provided information on current use and dose of multivitamins and use of other vitamin supplements.
For both cohorts, investigators repeatedly collected and updated information on several anthropometric and lifestyle factors such as weight, smoking status, alcohol use, coffee intake, and physical activity level. Information was also collected on several major risk factors for skin disease such as family history of melanoma, number of arm moles, natural hair color, sunburn susceptibility as a child or adolescent, number of lifetime blistering sunburns, type of tan after repeated sun exposure as a child or adolescent, and cumulative ultraviolet flux since baseline.
Study subjects reported new diagnoses biennially. After obtaining permission from participants, their medical and pathological records were acquired. Study physicians blinded to questionnaire information reviewed these records to confirm diagnoses
The study was approved by the institutional review boards of both Brigham and Women's Hospital and Harvard T.H Chan School of Public Health.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-Participants of these two cohorts
Exclusion Criteria:
- Participants with missing data on dietary intake at baseline
- Participants with a prior history of cancer (except non-melanoma skin cancer)
- For skin cancer, non-white participants because of low risk of skin cancer (such as melanoma) and small numbers.
- For melanoma, participants with in-situ melanomas, which comprise tumours restricted to the epidermis of the skin.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nurses' Health Study
See "Detailed Description"
|
Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)
|
Health Professionals Follow-Up Study
See "Detailed Description"
|
Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multiple skin diseases
Time Frame: Skin disease/cancer [ NHS: Time Frame: 1984 - 2010 ] [ HPFS: Time Frame: 1986 - 2010 ]. Person time contribution from date of return of questionnaire to date of first report of skin disease/death/end of follow-up (whichever came first)
|
Includes skin cancer, psoriasis, and other inflammatory and autoimmune skin diseases.
|
Skin disease/cancer [ NHS: Time Frame: 1984 - 2010 ] [ HPFS: Time Frame: 1986 - 2010 ]. Person time contribution from date of return of questionnaire to date of first report of skin disease/death/end of follow-up (whichever came first)
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA186107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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