Collecting Tumor Samples and Blood Biomarkers in Melanoma Patients
Molecular Characterisation of Serial Tumour Samples and Their Correlation With Circulating Biomarkers and Other Biospecimens Taken During the Clinical Course of Patients Receiving Treatment for Malignant Melanoma.
The Christie NHS Foundation Trust · NCT04493723
This study is collecting tumor and blood samples from people with advanced melanoma to see why some don’t respond to cancer treatments and to find clues that could help in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | The Christie NHS Foundation Trust (other) |
| Locations | 1 site (Manchester) |
| Trial ID | NCT04493723 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect tumor biopsies and blood samples from patients with advanced melanoma to understand why some patients develop resistance to anti-cancer treatments. Participants will provide samples before, during, and after their treatment as part of their routine care. The study will analyze these samples to identify predictive biomarkers of treatment resistance and to characterize genetic changes associated with circulating tumor markers. Informed consent will be obtained from all participants, and they may also provide additional samples if they choose to do so.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and over with locally advanced or metastatic melanoma who are undergoing treatment as part of their routine care.
Not a fit: Patients who are unable to provide informed consent or have significant bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of predictive biomarkers that help tailor treatments for melanoma patients, improving their outcomes.
How similar studies have performed: Other studies have shown promise in using tumor biopsies and blood biomarkers to understand treatment resistance in cancer, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of 16 years or more. 2. Patients must have given written informed consent. 3. Evidence of locally advanced or metastatic melanoma, i.e. stage III or IV disease. 4. Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A). 5. Full blood count and coagulation tests within acceptable parameters (if consenting to part A). Exclusion Criteria: 1. Inability to provide informed consent. 2. History of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling). 3. History of HIV, Hepatitis B/C or other transmissible human disease. 4. Any conditions where research biopsies or blood sampling may increase risk of complications for the patient and/or investigator, including high risk groups such as intravenous drug users.
Where this trial is running
Manchester
- The Christie — Manchester, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Lorigan, Prof — University of Manchester
- Study coordinator: Gupta, Dr
- Email: avinash.gupta@christie.nhs.uk
- Phone: 0161 446 3472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melanoma, Tumour Biopsy, Blood Biomarker