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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Skin cancer
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We are looking for new and better ways to manage melanoma, an aggressive type of skin cancer. Surgery to remove the melanoma will cure the majority of patients with early-stage disease. However, a small percentage of these patients will go on to develop further disease, which may spread to other places in their bodies. At present, following surgery, patients with early-stage melanoma can either choose to have close monitoring with regular scans and skin checks or they can have a year of drug treatment. This study is testing whether we can follow patients with regular blood tests looking for DNA that comes from the cancer (ctDNA) and only treat those patients that become ctDNA positive, indicating cancer is still present. Critically, this test can identify early melanoma relapse when it is not visible on imaging. Thus, we can reduce the amount of unnecessary drug treatment and potential side effects for patients by using ctDNA testing. Patients will remain in the study for at least 5 years and will be seen in hospital clinics.
This is a feasibility study, which means that the researchers are looking at whether a large-scale study could be possible by first of all working with a smaller number of participants. They want to know if they can recruit enough patients in 12 months and analyse blood tests promptly. If it is feasible, they will then be looking to expand DETECTION-2 into a much larger Phase III study which will involve a larger number of participants to compare treatments.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Known severe medical or physiological or psychological co-morbidities conditions that would compromise or impede participation or contraindications to therapeutics2. Pregnant or breastfeeding females3. Current other malignancy or history of another malignancy within the last 3 years. Patients who have been disease-free for 3 years, (i.e., patients with second malignancies that have been definitively treated at least 3 years ago) or patients with a history of completely resected non-melanoma skin cancer or melanoma in situ are eligible.4. In patients planned to have immune therapy only (including BRAF wild type), patients with active, known or suspected autoimmune disease are excluded from enrolment apart from those patients with the following conditions4.1. Type 1 diabetes mellitus 4.2. Rheumatoid arthritis not requiring disease-modifying drugs 4.3. Hypothyroidism only requiring hormone replacement 4.4. Skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment4.5. Autoimmune conditions not expected to recur in the absence of an external trigger. Many patients with these conditions have now been treated with immune therapy. A discussion about the potential risk of worsening of these conditions should be had with the patient prior to consent.5. In patients planned to have immune therapy only (including BRAF wild type), patients with a condition requiring ongoing/long-term (> 3 months) systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement steroid doses < = 10 mg daily prednisolone equivalent are permitted in the absence of active autoimmune disease. 6. Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.7. History of allergies or adverse drug reaction to any of the of the intended standard of care therapies or to any monoclonal antibody.8. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Paul
Lorigan
+44 (0)23 8120 5154
detection2@soton.ac.uk
The study is sponsored by The Christie NHS Foundation Trust and funded by Cancer Research UK.
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Or CPMS 58643
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