None listed
Conditions
Brief summary
Recent studies on melanoma have shown that survival and response to treatment can related to gut microbiome diversity and richness. All bacteria produce molecules, known as metabolites, that can alter immune cell function. This study aims to assess whether people with melanoma who are being treated with a checkpoint inhibitor (immunotherapy) have any key differences in their bacterial metabolites (metabolome) that may determine whether they are likely to respond to their immunotherapy treatment. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with resected and unresectable melanoma and you are undergoing checkpoint inhibitor therapy. Study details All participants who choose to enrol in this study will be asked to provide a blood sample and a faecal (stool) sample for testing. This will occur during a clinic appointment lasting no more than 20 minutes. Participants will be asked to provide these samples at the time of enrolment, at 6 weeks and then either (i) at the 6 month mark, or (ii) earlier if the immunotherapy treatment stops working. It is hoped this research will determine if there are any key metabolite differences between melanoma patients who do respond to immune checkpoint inhibitor therapy, and those do not respond to this treatment. We hope to use our research findings to investigate more effective cancer treatments for patients in the future.
Interventions
Patients with resected and unresectable melanoma who are undergoing checkpoint inhibitor therapy will undergo blood and faecal metabolomic profiling in order to identify the metabolites associated with successful immunotherapy responses. We will collect one tube of blood and one faecal sample at three time points during checkpoint inhibitor treatment. This includes baseline, week 6 and at 6 months or development of disease progression. The blood draw will take 10 minutes and the faecal collectio
Patients with resected and unresectable melanoma who are undergoing checkpoint inhibitor therapy will undergo blood and faecal metabolomic profiling in order to identify the metabolites associated with successful immunotherapy responses. We will collect one tube of blood and one faecal sample at three time points during checkpoint inhibitor treatment. This includes baseline, week 6 and at 6 months or development of disease progression. The blood draw will take 10 minutes and the faecal collection will be conducted at home. Patient data will be followed up for a total of 24 months post enrollment - this will be based on medical records.
Sponsors
Wesley Medical Research
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with resected and unresectable melanoma who are undergoing checkpoint inhibitor therapy.
Exclusion criteria
Patients with active, untreated brain metastases Patients on > 10mg prednisone at baseline Active autoimmune disease (excludes vitiligo, treated thyroid disease, diabetes) Crohn’s disease or ulcerative colitis The presence of any other neoplasm in the past 5 years – deemed ‘not under control’ Pregnancy Inability to give informed consent HIV Hepatitis B or C Prior treatment with immunotherapy – if patient had adjuvant immunotherapy – date of relapse must have been > = 6 months prior to study entry Active mental illness that prohibits study entry Radiotherapy within previous 4 weeks except to brain mets Concurrent use of any other investigational or experimental product or therapeutic
Outcome results
None listed