<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253666</url>
  </required_header>
  <id_info>
    <org_study_id>CA186107</org_study_id>
    <nct_id>NCT03253666</nct_id>
  </id_info>
  <brief_title>Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)</brief_title>
  <official_title>Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard School of Public Health (HSPH)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the relationships of dietary factors with the subsequent risk of dermatological&#xD;
      diseases (such as skin cancers and inflammatory or autoimmune dermatoses) in a cohort of&#xD;
      female registered nurses and male health professionals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population consisted of two ongoing cohorts: the Nurses' Health Study (NHS) and&#xD;
      Health Professionals Follow-Up Study (HPFS). The NHS began in 1976 when 121,700 female nurses&#xD;
      aged 33-55 years and residing in the United States responded to a baseline questionnaire. The&#xD;
      HPFS began in 1986 when 51,529 male health professionals aged 40-75 years and residing in the&#xD;
      United States completed a similar baseline questionnaire. Study investigators sent follow-up&#xD;
      questionnaires biennially to participants to update information on past medical history as&#xD;
      well as lifestyle factors.&#xD;
&#xD;
      Follow up was started in 1984 for the NHS and 1986 for the HPFS when diet was measured with&#xD;
      an expanded food frequency questionnaire (FFQ). Participants in the NHS responded to an ~130&#xD;
      item semi-quantitative FFQ in 1984, 1986, and then every four years thereafter, while those&#xD;
      in the HPFS responded to a similar FFQ in 1986 and then every four years thereafter. The FFQ&#xD;
      collected information on average intake of each food item over the past year. It also&#xD;
      specified a common serving size for each item. Participants could select from one of nine&#xD;
      intake frequency choices, ranging from less than once per month to six or more times per day.&#xD;
      Participants also provided information on current use and dose of multivitamins and use of&#xD;
      other vitamin supplements.&#xD;
&#xD;
      For both cohorts, investigators repeatedly collected and updated information on several&#xD;
      anthropometric and lifestyle factors such as weight, smoking status, alcohol use, coffee&#xD;
      intake, and physical activity level. Information was also collected on several major risk&#xD;
      factors for skin disease such as family history of melanoma, number of arm moles, natural&#xD;
      hair color, sunburn susceptibility as a child or adolescent, number of lifetime blistering&#xD;
      sunburns, type of tan after repeated sun exposure as a child or adolescent, and cumulative&#xD;
      ultraviolet flux since baseline.&#xD;
&#xD;
      Study subjects reported new diagnoses biennially. After obtaining permission from&#xD;
      participants, their medical and pathological records were acquired. Study physicians blinded&#xD;
      to questionnaire information reviewed these records to confirm diagnoses&#xD;
&#xD;
      The study was approved by the institutional review boards of both Brigham and Women's&#xD;
      Hospital and Harvard T.H Chan School of Public Health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Years</target_duration>
  <primary_outcome>
    <measure>Multiple skin diseases</measure>
    <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)</time_frame>
    <description>Includes skin cancer, psoriasis, and other inflammatory and autoimmune skin diseases.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">173229</enrollment>
  <condition>Skin Cancer</condition>
  <condition>Melanoma</condition>
  <condition>Non-melanoma Skin Cancer</condition>
  <condition>Psoriasis</condition>
  <condition>Rosacea</condition>
  <condition>Lupus Erythematosus</condition>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Nurses' Health Study</arm_group_label>
    <description>See &quot;Detailed Description&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Professionals Follow-Up Study</arm_group_label>
    <description>See &quot;Detailed Description&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrient Intake</intervention_name>
    <description>Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)</description>
    <arm_group_label>Health Professionals Follow-Up Study</arm_group_label>
    <arm_group_label>Nurses' Health Study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        See &quot;Detailed Description&quot;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Participants of these two cohorts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with missing data on dietary intake at baseline&#xD;
&#xD;
          -  Participants with a prior history of cancer (except non-melanoma skin cancer)&#xD;
&#xD;
          -  For skin cancer, non-white participants because of low risk of skin cancer (such as&#xD;
             melanoma) and small numbers.&#xD;
&#xD;
          -  For melanoma, participants with in-situ melanomas, which comprise tumours restricted&#xD;
             to the epidermis of the skin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://www.nurseshealthstudy.org/</url>
    <description>Nurse's Health Study</description>
  </link>
  <link>
    <url>https://sites.sph.harvard.edu/hpfs/</url>
    <description>Health Professionals Follow-Up Study</description>
  </link>
  <results_reference>
    <citation>Li WQ, Cho E, Weinstock MA, Mashfiq H, Qureshi AA. Epidemiological Assessments of Skin Outcomes in the Nurses' Health Studies. Am J Public Health. 2016 Sep;106(9):1677-83. doi: 10.2105/AJPH.2016.303315. Epub 2016 Jul 26.</citation>
    <PMID>27459457</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
    <investigator_full_name>Ashar Dhana</investigator_full_name>
    <investigator_title>Research Associate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Rosacea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253666
org study id: CA186107
nct id: NCT03253666
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: 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)
description: Includes skin cancer, psoriasis, and other inflammatory and autoimmune skin diseases.
arm group label: Nurses' Health Study
description: See "Detailed Description"
arm group label: Health Professionals Follow-Up Study
description: See "Detailed Description"
intervention type: Other
intervention name: Nutrient Intake
description: Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)
arm group label: Health Professionals Follow-Up Study
arm group label: Nurses' Health Study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://www.nurseshealthstudy.org/
description: Nurse's Health Study
url: https://sites.sph.harvard.edu/hpfs/
description: Health Professionals Follow-Up Study
citation: Li WQ, Cho E, Weinstock MA, Mashfiq H, Qureshi AA. Epidemiological Assessments of Skin Outcomes in the Nurses' Health Studies. Am J Public Health. 2016 Sep;106(9):1677-83. doi: 10.2105/AJPH.2016.303315. Epub 2016 Jul 26.
PMID: 27459457
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Ashar Dhana
investigator title: Research Associate
mesh term: Skin Neoplasms
mesh term: Psoriasis
mesh term: Dermatitis
mesh term: Rosacea
sharing ipd: Undecided