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Skin Ageing Signatures and Cancer (SASAC)

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ClinicalTrials.gov Identifier: NCT03265678
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
Queen Mary University of London

Brief Summary:

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.


Condition or disease
Skin Cancer

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Other
Official Title: Identification of a Genomic/Transcriptomic Signature for Ageing and Predisposition to Skin Cancer in Normal Sun-exposed Skin
Actual Study Start Date : June 2, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Arm
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.



Primary Outcome Measures :
  1. 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 ]
    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


Secondary Outcome Measures :
  1. Whole genome sequencing and transcriptomic analysis of normal skin samples [ Time Frame: 1 Year ]
    Comparison of genomic and transcriptomic molecular signature for skin ageing with known genomic and transcriptomic signatures for cSCC


Biospecimen Retention:   Samples With DNA
Skin and blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female participants will be approached for the study
Sampling Method:   Non-Probability Sample
Study Population
Potential participants will be identified amongst patients attending outpatient clinics in dermatology, ophthalmology and other general medical specialities for reasons other than skin cancer or inflammatory skin disease. If required, volunteers will also be recruited by advertising from amongst staff within the hospital and Queen Mary University of London. Participants will be identified by the dermatology consultant or research fellow working on this study.
Criteria

Inclusion Criteria:

  1. Able to give written informed consent prior to admission to this study.
  2. Female aged between 55 and 65 years.
  3. Willing and able to comply with clinical/photographic assessment and laboratory tests

Exclusion Criteria:

  1. Previous history of skin cancer, active inflammatory or other skin condition that in the opinion of the investigator may affect the skin ageing assessment.
  2. Feverish symptoms which lasted for ≥48 hours prior to study entry.
  3. Currently suffering from or having suffered during the last month, with any common systemic disease except arterial hypertension.
  4. Received any of the following treatment for more than 6 months during the last two years: hypo or hyperthyroidism treatment, corticoids, non-steroids anti-inflammatory, antihistamines, immunosuppressive treatments, diuretics, antibiotics, anticoagulants, beta blockers.
  5. Currently experiencing or having experienced in the last two months prior to study entry problems affecting the skin of the face or forearm for instance acne, eczema, psoriasis, seborroheic dermatitis, herpes zoster.
  6. Currently receiving or having received in the last two months prior to study entry any of the following dermatological treatments for more than 8 days: hormone based cream, retinoid based facial cream, > 8% concentration alpha hydroxy acid based cream, topical steroids, antibiotics and antifungals
  7. Previous facial aesthetic treatments such as: lifting, chemical peeling, dermabrasion, electrocoagulation, laser, sclerotherapy, reconstructive surgery, botox injection, filler injection.
  8. Currently using a hormone based cream that is applied on the forearm for hormonal replacement therapy.
  9. Have had a change in skin colour during within one month prior to study entry due to sun exposure
  10. Had a session of UV therapy for treatment purposes or in a beauty salon within one month prior to study entry.
  11. Use of a self-tanning product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265678


Contacts
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Contact: SASAC Coordinator 020 7882 8489 bci-sasac@qmul.ac.uk

Locations
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United Kingdom
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 1BB
Contact: Prof Catherine Harwood       Catherine.Harwood@bartshealth.nhs.uk   
Sponsors and Collaborators
Queen Mary University of London
University of Edinburgh
Investigators
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Principal Investigator: Prof Catherine Harwood Queen Mary University of London

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03265678     History of Changes
Other Study ID Numbers: 11701
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases