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BETHELLS Basal Cell Carcinoma Study

Auckland

Basal cell carcinoma (BCC) is a common cancer.  Nodular BCC (nBCC) is the most common type of BCC. It usually appears as a pearly or flesh-coloured, shiny lump, but can take other forms. It most often forms on the face, neck and other areas exposed to the sun. Although nBCC is the least dangerous type of skin cancer and rarely spreads, it can cause tissue damage if left untreated. These tumours are usually surgically removed.  

Description

What to expect

Study details

Ages

18 years or older

Duration

Up to 10 clinic visits over 52 weeks (1 year)

Compensation

You will be reimbursed for your time and travel costs

Eligibility Criteria

  • 18+ years with a nodular basal cell carcinoma
  • Have light to medium skin tone (required for laser light safety)
  • Otherwise, healthy
  • Willing to undergo study procedures, including tumour punch biopsies

Locations

Auckland

Description

Approximately 75-80% of non-melanoma skin cancers are basal cell carcinomas (BCC). Nodular BCCs comprise around 80% of all BCCs.  They tend to grow slowly, over a number of months. They rarely metastasise, and therefore are rarely life-threatening, but can cause local tissue destruction, impacting quality of life and morbidity as they commonly form on the face.  

Most basal cell carcinomas are treated with surgery, cryosurgery and radiotherapy.  

About the investigational product 
The study product (TSK-001) is a potential new treatment for skin cancers. The study product is injected into your nBCC and then exposed to NIR light to heat and kill the tumour cells. After the injection, you’ll be monitored for about 2 hours to ensure you don’t have any reactions.

What to expect

Study Aim
The main purpose of this study is to learn about the study product and evaluate its efficacy and safety in clearing nBCC tumours.  
Reason to participate
Your involvement in this study may help advance scientific knowledge that could lead to the development of a new treatment for people with nBCC. Other reasons to participate may include:  
  • Receive treatment and monitoring of your nBCC by a skin specialist and NZ doctors and nurses  
  • Your nBCC may clear without the need for surgery.  
 
What does taking part involve? 
Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you.  If you wish to take part and are eligible, we would like to see you for up to 10 clinic visits over 52 weeks (1 year).  

During visits, we conduct health checks, which may include physical examinations. 
Other procedures throughout this study may include:  
  • Vital sign checks (blood pressure, heart rate, temperature)  
  • ECGs to monitor heart activity  
  • Blood, urine and tumour samples  
  • Questions about medications, adverse events and pain.  
The study product is injected into your nBCC tumour, followed by exposure to the NIR light. You will be monitored for 2 hours after the injection. The study aims to investigate whether the study product, in conjunction with NIR light, is effective and safe for treating nBCC tumours.

About 78 people worldwide are participating in this study.

Apply now

Fill out your details, and our team will be in touch to discuss your potential involvement in this study and answer any questions you may have.

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