Serial Tumour Biopsies and Blood Biomarkers in Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorThe Christie NHS Foundation Trust
About this trial
Recent advances in understanding how cancer develops and spreads have led to effective new treatments and improved outcomes for patients with melanoma. However, we know that these new treatments do not work for all patients: some do not respond to them and some initially respond but then develop resistance. The overall aim of this study will be to collect tumour biopsies, biomarkers present in the blood, and other biological specimens which can be used to try to understand why resistance to anti-cancer treatment occurs, and to develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant melanoma.
The study will be open to NHS patients aged 16 and over, who have been diagnosed with advanced melanoma, and who will be receiving treatment for their disease as part of their routine care. Patients will be asked to provide samples from tumour biopsies before, during and after treatment. We will also ask for blood samples to look at biomarkers in the blood and see how these correspond with tumour samples, which will further help us to understand treatment response. Biomarkers are substances in the body that can be measured and help indicate how a disease is developing. It is hoped that soon we will be able to monitor cancer by analysing a patient's blood samples, thus reducing the need for biopsies. As blood tests could be taken more frequently, signs that patients are becoming resistant to treatments could be picked up sooner.
As well as monitoring biomarkers, we would also like to understand what happens to the healthy cells surrounding the tumour during treatment. This will improve our understanding of how cells adapt and respond to treatments, and may eventually lead to the discovery of new biomarkers to help predict which patients will develop resistance to certain treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of 16 years or more.
Patients must have given written informed consent.
Evidence of locally advanced or metastatic melanoma, i.e. stage III or IV disease.
Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).
Disqualifiers
Inability to provide informed consent.
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).
History of HIV, Hepatitis B/C or other transmissible human disease.
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.
Trial population
Patients with stage III or IV melanoma undergoing systemic therapy at The Christie hospital
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Surgery
Procedure/SurgeryTo collect tumour tissue
Venepuncture
Procedure/SurgeryTo collect blood samples
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: All participants2 interventions
Trial outcomes
Primary outcomes
1
The number of patients who consent to have additional samples taken for research purposes and the number of research samples collected.
This is primarily a sample collection study, where tissue will be used in future experiments to further understand mechanisms of disease resistance. This study will however assess patients acceptability to enrol in a study, where biological samples are taken purely for research, and not part of routine care.
Time frame
Duration of study, 300 participants over 16 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Christie NHS Foundation Trust
Lead sponsor
University of Manchester
Collaborator
Source ClinicalTrials.gov