Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03253666
Recruitment Status : Enrolling by invitation
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Brown University
Information provided by (Responsible Party):
Ashar Dhana, Harvard School of Public Health

Brief Summary:
To determine the relationships of dietary factors with the subsequent risk of dermatological diseases (such as skin cancers and inflammatory or autoimmune dermatoses) in a cohort of female registered nurses and male health professionals.

Condition or disease Intervention/treatment
Skin Cancer Melanoma Non-melanoma Skin Cancer Psoriasis Rosacea Lupus Erythematosus Atopic Dermatitis Other: Nutrient Intake

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 173229 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)
Actual Study Start Date : August 1980
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Group/Cohort Intervention/treatment
Nurses' Health Study
See "Detailed Description"
Other: Nutrient Intake
Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)

Health Professionals Follow-Up Study
See "Detailed Description"
Other: Nutrient Intake
Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See "Detailed Description"
Criteria

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.

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Ashar Dhana, Research Associate, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03253666     History of Changes
Other Study ID Numbers: CA186107
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Skin Neoplasms
Rosacea
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Neoplasms by Site
Neoplasms
Nutrients
Dermatologic Agents
Growth Substances
Physiological Effects of Drugs