Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics (PRIMM)
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|ClinicalTrials.gov Identifier: NCT03643289|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : February 27, 2020
|Condition or disease|
This pilot project will assess the gut microbiome with metagenome sequencing before and after starting immunotherapy in stage 3 and 4 melanoma patients. The project will assess the impact of the gut microbiome on treatment response rates and side effects induced by immunotherapy.
200 stage 4 and 250 stage 3 melanoma patients naive to immunotherapy will be recruited from melanoma clinics. Stool samples will be donated pre-treatment and at follow-up visits throughout treatment. An additional sample will also be requested in the event of disease progression or toxicity necessitating treatment delay or discontinuation. An accompanying stool sample questionnaire will be completed at each sampling time point with the optional completion of a 24-hour recall food diary.
Blood samples will also be taken before and after starting immunotherapy treatment, with gastrointestinal, food frequency, quality of life questionnaires administered at baseline. An optional tumour biopsy if safe and accessible, is requested from patients in the stage 4 cohort before and after starting immunotherapy.
Microbiome data from melanoma patients will be compared with the TwinsUK healthy control gut microbiome data on more than 3000 healthy adults. This analysis will help us assess if there are major differences between the microbiome composition in the melanoma cases prior to therapy compared to the control gut microbiome data from TwinsUK.
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics|
|Actual Study Start Date :||April 4, 2018|
|Estimated Primary Completion Date :||May 2, 2023|
|Estimated Study Completion Date :||May 2, 2023|
Patients with stage 4 melanoma due to commence immunotherapy. Patients should be naïve to immunotherapy.
Patients with stage 3 melanoma who are naïve to immunotherapy
- Gut microbiome diversity via measurement of bacterial species in stool samples [ Time Frame: 3-5 years ]Gut microbiome diversity and peripheral blood mononuclear cells immunophenotyping in relation to responses to treatment and side effects in patients with stage 3 or stage 4 melanoma receiving immunotherapy
- Peripheral blood monocyte measurements to determine the characterisation of peripheral blood mononuclear cells (immunophenotyping) and inflammatory markers before and after starting immunotherapy treatment. [ Time Frame: 3-5 years ]Gut microbiome diversity and peripheral blood mononuclear cells immunophenotyping in relation to responses to treatment and side effects in patients with stage 3 or stage 4 melanoma receiving immunotherapy.
- Side effects as determined by CTCAE scale Common Toxicity Criteria for Adverse Events v5.03 [ Time Frame: 3-5 years ]Gut microbiome diversity and peripheral blood mononuclear cells immunophenotyping in relation to responses to treatment and side effects in patients with stage 3 or stage 4 melanoma receiving immunotherapy.
- Analysis of optional punch biopsy samples before and after commencing immunotherapy treatment in patients with stage 4 melanoma [ Time Frame: 3-5 years ]Exploratory analysis to examine the association between the gut microbiome and the presence of tumour infiltrates and regulatory environments.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643289
|Contact: Clare Stockwell||02071887188 (x86754)||firstname.lastname@example.org|
|Contact: Paul Nathan||0203 826 email@example.com|
|East and North Hertfordshire NHS Trust||Recruiting|
|Northwood, Middlesex, United Kingdom, HA62RN|
|Contact: Paul Nathan 02038262444 firstname.lastname@example.org|
|Guy's and St. Thomas' NHS Foundation Trust||Recruiting|
|London, United Kingdom|
|Contact: Mark Harries|
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom|
|Contact: Paul Lorrigan|
|Lancashire Teaching Hospitals NHS Foundation Trust||Recruiting|
|Preston, United Kingdom|
|Contact: Ruth Board|
|The Clatterbridge Cancer Centre||Recruiting|
|Wirral, United Kingdom|
|Contact: Joseph Sacco|