Skin CancerSASACNCT03265678
Skin Ageing Signatures and Cancer
An observational study of Skin Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Skin Cancer
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2017to 22 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- Able to give written informed consent prior to admission to this study.
- Female aged between 55 and 65 years.
- Willing and able to comply with clinical/photographic assessment and laboratory tests
Who cannot join
- Previous history of skin cancer, active inflammatory or other skin condition that in the opinion of the investigator may affect the skin ageing assessment.
- Feverish symptoms which lasted for ≥48 hours prior to study entry.
- Currently suffering from or having suffered during the last month, with any common systemic disease except arterial hypertension.
- 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.
- 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.
- 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
Show all 11Show fewer
- Previous facial aesthetic treatments such as: lifting, chemical peeling, dermabrasion, electrocoagulation, laser, sclerotherapy, reconstructive surgery, botox injection, filler injection.
- Currently using a hormone based cream that is applied on the forearm for hormonal replacement therapy.
- Have had a change in skin colour during within one month prior to study entry due to sun exposure
- Had a session of UV therapy for treatment purposes or in a beauty salon within one month prior to study entry.
- Use of a self-tanning product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of a Genomic/Transcriptomic Signature for Ageing and Predisposition to Skin Cancer in Normal Sun-exposed Skin
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.
Read the 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.
- Conditions
- Skin Cancer
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: 1 Year
Secondary outcomes (1)
Whole genome sequencing and transcriptomic analysis of normal skin samples
Comparison of genomic and transcriptomic molecular signature for skin ageing with known genomic and transcriptomic signatures for cSCC
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start2 Jun 2017
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Prof Catherine Harwood, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265678
- Sponsor's protocol ID
- 11701
- Acronym
- SASAC
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2017
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a Genomic/Transcriptomic Signature for Ageing and Predisposition to Skin Cancer in Normal Sun-exposed Skin
- ClinicalTrials.gov ID
- NCT03265678
- Acronym / sponsor ID
- SASAC / 11701
- Conditions
- Skin Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Edinburgh
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Able to give written informed consent prior to admission to this study.
- Female aged between 55 and 65 years.
- Willing and able to comply with clinical/photographic assessment and laboratory tests
Key exclusion criteria (11 listed)
- Previous history of skin cancer, active inflammatory or other skin condition that in the opinion of the investigator may affect the skin ageing assessment.
- Feverish symptoms which lasted for ≥48 hours prior to study entry.
- Currently suffering from or having suffered during the last month, with any common systemic disease except arterial hypertension.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Whole genome sequencing and transcriptomic analysis of normal skin samples
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Catherine Harwood principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.