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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 : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
East and North Hertfordshire NHS Trust

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 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.


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Study Type : Observational
Estimated Enrollment : 160 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 related topics: Melanoma




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Stool samples


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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 4 melanoma
Criteria

Inclusion Criteria:

- Patients aged over the age of 18 years with stage 4 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

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: Amrita Vijay 020718852588 Amrita.vijay@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   
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
King's College London

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Responsible Party: East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT03643289     History of Changes
Other Study ID Numbers: RD2016-56
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
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