My experience in a Clinical Trial

International Clinical Trial Day is the 20th May. Our Digital Communications & Marketing Officer volunteered for the skin scan clinical trial, being held at the Clinical Research Facilty at the PA Hospital, to learn more about the process. This is her story. 

One of the many physical features I inherited from my Dad - moles. Lots of them. I've got that kind of skin that offers a smorgasbord of options for a researcher looking to study moles - flat ones, raised ones, ones that change, pink ones, brown ones, big ones, small ones. Remember that Austin Powers scene where he runs off a string of puns about moles? That could have been inspired by swimming days at my highschool. Don't say mole. My molestake. Guacamole. Moley moley moley moley moley. Anyway...

Fortunately, I have been lucky with my family GP who has kept an eye on my skin since I was a sunbathing teenager, going so far as to sketch changes in my moles on her notes back in the days before computerised records. Imagine how excited I was, as a technology geek 20 years into my digital career, to learn about the 3D skin scan right here in my workplace. 

This is my experience in a clinical trial which looks at the genetic markers for melanoma, a type of skin cancer. It is a non-invasive trial which involves being photographed by a high tech series of cameras to produce a 3d avatar of the skin surface. Once the 3d scan is complete, moles larger than 5mm are marked on the avatar and these are photographed again even closer.

To start the process, I emailed the Dermatology Centre and made an appointment. The appointment started with the consent forms, which explained what will happen to my samples. The samples will be used in a variety of ways including:

• Images used in text books and for educational purposes
• 3d avatar used for analysis and as a teaching tool
• For analysis now and to store for future use

The consent forms also explain that you can withdraw at any time. Permission was requested to get my relevant records from my doctor. Questions include genetic information about parents with or without melanoma, skin hair and eye colour plus the standard questions about medication and health problems.

The paperwork was conducted in a clinic room at the Clinical Research Facility in the PA Hospital, right next to the Translational Research Institute. The physical tests are conducted in the room next door. Before heading to the 3d scanner, a quick trip to the scales and tape measure to record weight and height.

The first test is a skin tone test, where a type of photo was taken of 3 areas of my skin (outer arm, inner elbow, inner arm near armpit). After this test, I stood in the scanner with my feet apart, arms up and elbows bent to offer the most skin coverage for the camera.

The scanner is 46 high resolution Digital SLR cameras suspended on scaffolding with flashes and lenses selected for the clearest images. These are then transferred by a router to the software in the nearby computer which takes about 5 - 10 minutes to stitch the images together. This creates the 3d avatar. Moles and freckles larger than 5mm are marked on the avatar.

While this is taking place I was handed a plastic tube to fill with spit to get some DNA for gene testing. This bit was more challenging than I expected!

The marked moles were then photographed closer using a special macro camera. I could see them on the computer screen - some of them are works of art (almost). And more than a little gross. The images and data are documented and kept together in a file which forms a genetic and skin profile of me. I'll probably never know, but one day I might see one of my own moles enlarged and staring back at me from a skin cancer billboard or a training text book!

This entire process took about 50 minutes although it is recommended to allow between 1 and 2 hours for the total process just in case it takes longer than expected to document your skin.

And, that's it! As this is a skin trial and DNA from your spit is used to study the genetic details for the study, you do not need to give any blood or take any medication so the risk to you is low. But putting those lifelong pain-in-the-butt moles to good use was definitely worth the hour of my time. 

Frequently Asked Questions?

What happens if the trial finds a problem with my moles?

You can elect to be notified if anything abnormal is discovered in your skin analysis. From there, you can request the photos and report be sent to your GP who can then refer you to a skin specialist. You can choose to return to the Dermatology Clinic at the PA Hospital where the study is conducted and can, again optionally, contribute further data to the study.

Any legal issues to consider?

The consent form is simple & the request for data sharing is relevant to the trial but you do have to be comfortable with the trial operators accessing your relevant records with your doctor. You can opt out at any time. One of the questions asks if you'd like to be informed if a genetic defect is identified in your genetic test. Such genetic defects may put you at a higher risk of an unrelated treatable condition and knowing about them may have both positive and negative effects so you should consider your answer carefully. The staff at the Dermatology Research Centre will be more than happy to talk to you in more detail about this either before or during your appointment.

Did it hurt?

There's nothing painful in this trial, unless you're uncomfortable in your underwear! The spit sample was a little challenging though so make sure to be well hydrated long before heading to your appointment, because drinking water at the time will dilute the sample. The spit collection tube requires about 10ml of clear spit, not the foamy bit. It's harder than it sounds!

How do we volunteer?

Contact Katie Lee on [email protected] to make an appointment during business hours.

Follow Up

After the trial, I was contacted by a clinician at the Dermatology Research Centre for further study of one of my moles which had shown up as ‘atypical’. An email advised me that they had “identified a lesion on my lower back that looks like an atypical mole”, which is a mole that can appear like a melanoma and is at higher risk of developing into a melanoma – but isn’t necessarily one.

Studies like this, with incredibly high resolution images, are designed to help understand the difference between moles that will become a melanoma and ones that could, or just look like it.

The particular mole in question had already had the top knocked off years prior during contact sport, so the shave biopsy was to remove cells which could be studied further.

This came back clear, and I am now confident that my tested moles (over 5mm) are safe although this doesn't replace my regular skin checkups (yet). I’m also pleased that my data was able to contribute to the study and help the researchers to learn more about the types of moles which are at high risk. I will continue to work with my GP to keep an eye on my skin, as I have always done, and will definitely participate in the study again. 

> To participate in this clinical study please contact [email protected]