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 : August 28, 2018
|Condition or disease|
This pilot project will assess the gut microbiome with metagenome sequencing before and after starting immunotherapy in stage 4 melanoma patients. The project will assess the impact of the gut microbiome on treatment response rates and side effects induced by immunotherapy. 160 stage 4 melanoma patients naive to immunotherapy will be recruited from the melanoma clinic at Mount Vernon Cancer Centre (part of East and North Hertfordshire NHS Trust) as well as Guy's and St Thomas' NHS Foundation Trust and UCLH NHS Foundation Trust. 80 cases will be recruited at Mount Vernon Cancer Centre and 40 cases at Guy's and St Thomas' Foundation Trust and UCLH respectively. Stool samples will be donated pre-treatment and at three follow up visits at 3 weekly intervals until week 9.An additional sample will also be requested in the event of disease progression. 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 at week 0 and week 3 with gastrointestinal, food frequency, quality of life questionnaires administered at baseline. The 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 :||160 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|
- Gut microbiome diversity via measurement of bacterial species in stool samples [ Time Frame: 5 years ]Gut microbiome diversity and peripheral blood mononuclear cells immunophenotyping in relation to responses to treatment and side effects in advanced melanoma patients receiving immunotherapy.
- Peripheral blood monocyte measurements to determine the characterisation of peripheral blood mononuclear cells (immunophenotyping) and inflammatory markers before and after starting treatment. [ Time Frame: 5 years ]Gut microbiome diversity and peripheral blood mononuclear cells immunophenotyping in relation to responses to treatment and side effects in advanced melanoma patients receiving immunotherapy.
- Side effects as determined by CTCAE scale Common Toxicity Criteria for Adverse Events v4.03 [ Time Frame: 5 years ]Gut microbiome diversity and peripheral blood mononuclear cells immunophenotyping in relation to responses to treatment and side effects in advanced melanoma patients receiving immunotherapy.
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: Amrita Vijay||020718852588||Amrita.email@example.com|
|Contact: Paul Nathan||0203 826 firstname.lastname@example.org|
|East and North Hertfordshire NHS Trust||Recruiting|
|Northwood, Middlesex, United Kingdom, HA62RN|
|Contact: Paul Nathan 02038262444 email@example.com|