<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/NCT03265678</url>
  </required_header>
  <id_info>
    <org_study_id>11701</org_study_id>
    <nct_id>NCT03265678</nct_id>
  </id_info>
  <brief_title>Skin Ageing Signatures and Cancer</brief_title>
  <acronym>SASAC</acronym>
  <official_title>Identification of a Genomic/Transcriptomic Signature for Ageing and Predisposition to Skin Cancer in Normal Sun-exposed Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this study is to identify genetic patterns in normal ageing skin in order to&#xD;
      better understand age-related changes.&#xD;
&#xD;
      Data has suggested that skin ageing has a genetic basis and past studies have identified&#xD;
      genes that promote skin aging due to sun exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use new tools in an attempt to understand the small changes that take place&#xD;
      in skin and may be linked to skin ageing either due to age or the effect of the sun. Some&#xD;
      data suggests that these changes may have a genetic basis.&#xD;
&#xD;
      In this study, the doctor will use a clinical scale to assess the participants skin type, the&#xD;
      scale will range from 1-5 with 1 being fairer skin types and 5 being darker skin types. The&#xD;
      doctors will select 10 female participants who meet the required skin types (1-4), aged&#xD;
      between 55 and 65 years who attend clinics for reasons other than skin cancer or other skin&#xD;
      diseases. 5 of these patients will have high levels of skin ageing and 5 will have low levels&#xD;
      of skin ageing as defined by a set of pre-defined criteria. The criteria will be identified&#xD;
      by examining the skin on the participants face and forearm. The study sponsor will collect&#xD;
      skin and blood samples from all participants in the high and low skin ageing groups and these&#xD;
      will be sent to a specialist laboratory for DNA and RNA analysis (genetic analysis).&#xD;
&#xD;
      The study sponsor hope that this will help us understand the effects of ageing on skin's&#xD;
      normal functions but also help us interpret results coming out of other genetic studies in&#xD;
      skin cancer. This information will help to better understand the changes linked with the&#xD;
      development of skin cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2, 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment of 10 patients with high or low skin ageing scores and collection of normal sun exposed and non-sun exposed skin and blood for genetic analysis.</measure>
    <time_frame>1 Year</time_frame>
    <description>Identify a genomic/transcriptomic molecular signature for skin ageing by correlation of whole genome sequencing and transcriptomic profiles of normal skin and clinically evaluated skin ageing scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole genome sequencing and transcriptomic analysis of normal skin samples</measure>
    <time_frame>1 Year</time_frame>
    <description>Comparison of genomic and transcriptomic molecular signature for skin ageing with known genomic and transcriptomic signatures for cSCC</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Arm</arm_group_label>
    <description>Registered participants will undergo a clinical assessment to determine whether they have high or low levels of skin ageing. The study will recruit 5 subjects with low levels of skin ageing and 5 subjects with high levels of skin ageing. Recruited patients will undergo skin punch biopsies, blood sampling and collection of lifestyle data.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Skin and blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Potential participants will be identified amongst patients attending outpatient clinics in&#xD;
        dermatology, ophthalmology and other general medical specialities for reasons other than&#xD;
        skin cancer or inflammatory skin disease. If required, volunteers will also be recruited by&#xD;
        advertising from amongst staff within the hospital and Queen Mary University of London.&#xD;
        Participants will be identified by the dermatology consultant or research fellow working on&#xD;
        this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to give written informed consent prior to admission to this study.&#xD;
&#xD;
          2. Female aged between 55 and 65 years.&#xD;
&#xD;
          3. Willing and able to comply with clinical/photographic assessment and laboratory tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history of skin cancer, active inflammatory or other skin condition that in&#xD;
             the opinion of the investigator may affect the skin ageing assessment.&#xD;
&#xD;
          2. Feverish symptoms which lasted for ≥48 hours prior to study entry.&#xD;
&#xD;
          3. Currently suffering from or having suffered during the last month, with any common&#xD;
             systemic disease except arterial hypertension.&#xD;
&#xD;
          4. Received any of the following treatment for more than 6 months during the last two&#xD;
             years: hypo or hyperthyroidism treatment, corticoids, non-steroids anti-inflammatory,&#xD;
             antihistamines, immunosuppressive treatments, diuretics, antibiotics, anticoagulants,&#xD;
             beta blockers.&#xD;
&#xD;
          5. Currently experiencing or having experienced in the last two months prior to study&#xD;
             entry problems affecting the skin of the face or forearm for instance acne, eczema,&#xD;
             psoriasis, seborroheic dermatitis, herpes zoster.&#xD;
&#xD;
          6. Currently receiving or having received in the last two months prior to study entry any&#xD;
             of the following dermatological treatments for more than 8 days: hormone based cream,&#xD;
             retinoid based facial cream, &gt; 8% concentration alpha hydroxy acid based cream,&#xD;
             topical steroids, antibiotics and antifungals&#xD;
&#xD;
          7. Previous facial aesthetic treatments such as: lifting, chemical peeling, dermabrasion,&#xD;
             electrocoagulation, laser, sclerotherapy, reconstructive surgery, botox injection,&#xD;
             filler injection.&#xD;
&#xD;
          8. Currently using a hormone based cream that is applied on the forearm for hormonal&#xD;
             replacement therapy.&#xD;
&#xD;
          9. Have had a change in skin colour during within one month prior to study entry due to&#xD;
             sun exposure&#xD;
&#xD;
         10. Had a session of UV therapy for treatment purposes or in a beauty salon within one&#xD;
             month prior to study entry.&#xD;
&#xD;
         11. Use of a self-tanning product&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only female participants will be approached for the study</gender_description>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Prof Catherine Harwood</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary University of London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>SASAC Coordinator</last_name>
    <phone>020 7882 8489</phone>
    <email>bci-sasac@qmul.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof Catherine Harwood</last_name>
      <email>Catherine.Harwood@bartshealth.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03265678
org study id: 11701
nct id: NCT03265678
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to identify genetic patterns in normal ageing skin in order to
      better understand age-related changes.

      Data has suggested that skin ageing has a genetic basis and past studies have identified
      genes that promote skin aging due to sun exposure.
This study will use new tools in an attempt to understand the small changes that take place
      in skin and may be linked to skin ageing either due to age or the effect of the sun. Some
      data suggests that these changes may have a genetic basis.

      In this study, the doctor will use a clinical scale to assess the participants skin type, the
      scale will range from 1-5 with 1 being fairer skin types and 5 being darker skin types. The
      doctors will select 10 female participants who meet the required skin types (1-4), aged
      between 55 and 65 years who attend clinics for reasons other than skin cancer or other skin
      diseases. 5 of these patients will have high levels of skin ageing and 5 will have low levels
      of skin ageing as defined by a set of pre-defined criteria. The criteria will be identified
      by examining the skin on the participants face and forearm. The study sponsor will collect
      skin and blood samples from all participants in the high and low skin ageing groups and these
      will be sent to a specialist laboratory for DNA and RNA analysis (genetic analysis).

      The study sponsor hope that this will help us understand the effects of ageing on skin's
      normal functions but also help us interpret results coming out of other genetic studies in
      skin cancer. This information will help to better understand the changes linked with the
      development of skin cancer.
observational model: Other
time perspective: Other
measure: Recruitment of 10 patients with high or low skin ageing scores and collection of normal sun exposed and non-sun exposed skin and blood for genetic analysis.
time frame: 1 Year
description: Identify a genomic/transcriptomic molecular signature for skin ageing by correlation of whole genome sequencing and transcriptomic profiles of normal skin and clinically evaluated skin ageing scores
measure: Whole genome sequencing and transcriptomic analysis of normal skin samples
time frame: 1 Year
description: Comparison of genomic and transcriptomic molecular signature for skin ageing with known genomic and transcriptomic signatures for cSCC
arm group label: Arm
description: Registered participants will undergo a clinical assessment to determine whether they have high or low levels of skin ageing. The study will recruit 5 subjects with low levels of skin ageing and 5 subjects with high levels of skin ageing. Recruited patients will undergo skin punch biopsies, blood sampling and collection of lifestyle data.
Skin and blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only female participants will be approached for the study
minimum age: 55 Years
maximum age: 65 Years
last name: Prof Catherine Harwood
role: Principal Investigator
affiliation: Queen Mary University of London
last name: SASAC Coordinator
phone: 020 7882 8489
email: bci-sasac@qmul.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Skin Neoplasms