Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics (PRIMM)
研究概览
地位
条件
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Clare Stockwell
- 电话号码:02071887188 (x86754)
- 邮箱:clare.1.stockwell@kcl.ac.uk
研究联系人备份
- 姓名:Paul Nathan
- 电话号码:0203 826 2444
- 邮箱:researchanddevelopment.enh-tr@nhs.net
学习地点
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London、英国
- 招聘中
- Guy's and St. Thomas' NHS Foundation Trust
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接触:
- Mark Harries
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Manchester、英国
- 招聘中
- The Christie NHS Foundation Trust
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接触:
- Paul Lorrigan
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Preston、英国
- 招聘中
- Lancashire Teaching Hospitals NHS Foundation Trust
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Wirral、英国
- 招聘中
- The Clatterbridge Cancer Centre
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接触:
- Joseph Sacco
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Middlesex
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Northwood、Middlesex、英国、HA62RN
- 招聘中
- East and North Hertfordshire NHS Trust
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接触:
- Paul Nathan
- 电话号码:02038262444
- 邮箱:researchanddevelopment.enh-tr@nhs.net
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients aged over the age of 18 years with advanced melanoma due to receive first line systemic treatment with immunotherapy with a checkpoint inhibitor alone or in combination.
Exclusion Criteria:
- Patients who have had systemic anti-cancer treatment for locally advanced or metastatic disease.
- Patients unable to consent because of language barrier or inability to consent.
- Patients unable to collect or send the stool samples for geographical, social or psychological reasons.
- Persons benefitting from protection system of adults (including guardianship and curatorship)
- Pregnant or breastfeeding women
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Cohort A
Patients with stage 4 melanoma due to commence immunotherapy.
Patients should be naïve to immunotherapy.
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Cohort B
Patients with stage 3 melanoma who are naïve to immunotherapy
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Gut microbiome diversity via measurement of bacterial species in stool samples
大体时间: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
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3-5 years
|
Peripheral blood monocyte measurements to determine the characterisation of peripheral blood mononuclear cells (immunophenotyping) and inflammatory markers before and after starting immunotherapy treatment.
大体时间: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.
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3-5 years
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Side effects as determined by CTCAE scale Common Toxicity Criteria for Adverse Events v5.03
大体时间:3-5 years
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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.
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3-5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Analysis of optional punch biopsy samples before and after commencing immunotherapy treatment in patients with stage 4 melanoma
大体时间:3-5 years
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Exploratory analysis to examine the association between the gut microbiome and the presence of tumour infiltrates and regulatory environments.
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3-5 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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