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Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics (PRIMM)

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ClinicalTrials.gov Identifier: NCT03643289
Recruitment Status : Unknown
Verified February 2020 by East and North Hertfordshire NHS Trust.
Recruitment status was:  Recruiting
First Posted : August 22, 2018
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
East and North Hertfordshire NHS Trust

Study Description
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Brief Summary:
This study will investigate the effects of gut microbiome diversity (richness in terms of many bacterial species in the gut) on responses and side effects of immunotherapy in advanced melanoma patients. Immunotherapy for melanoma is especially damaging for the gut with colitis which can lead to death and significant morbidity with repeated hospital admissions. The richness of the microbiome in the gut may be protective against colitis and other side effects but this needs to be confirmed. There is also some preliminary evidence that the gut microbiome diversity can enhance responses to immunotherapy in cancer but this has been shown in small numbers of melanoma patients.

Condition or disease
Melanoma (Skin)

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
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Group/Cohort
Cohort A
Patients with stage 4 melanoma due to commence immunotherapy. Patients should be naïve to immunotherapy.
Cohort B
Patients with stage 3 melanoma who are naïve to immunotherapy


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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
Stool samples, blood samples, tissue samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stage 3 or 4 melanoma
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Clare Stockwell 02071887188 (x86754) clare.1.stockwell@kcl.ac.uk
Contact: Paul Nathan 0203 826 2444 researchanddevelopment.enh-tr@nhs.net

Locations
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United Kingdom
East and North Hertfordshire NHS Trust Recruiting
Northwood, Middlesex, United Kingdom, HA62RN
Contact: Paul Nathan    02038262444    researchanddevelopment.enh-tr@nhs.net   
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         
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
King's College London
More Information
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Responsible Party: East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT03643289    
Other Study ID Numbers: RD2016-56
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research results will be published in international journals and presented at scientific meetings.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas