Polish Microbiome Map

Knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years. Nonetheless, there is no reference set of information about the microbiome in Poland. The development of such a reference will allow polish scientists conducting research in the field of interaction between gut flora components and such characteristics as lifestyle, certain diseases or patient's responses for treatment. Following the example of such countries as the United States, investigators propose to build a unique set of scientific processed information describing the variability of the polish population microbiome (Polish Microbiome Map). The investigators will provide a reliable dataset that will characterize the gut microbiomes and their diversity in the polish population. Additionally, thanks to the creation of the standard protocol for microbiome data collection the research conducted by the MMP users will be comparable with the information deposited in MMP.

Study Overview

• Status: Unknown
• Conditions: Melanoma; Healthy Volunteers; Metagenome; Immunotherapy; Microbiome
• Intervention / Treatment: Biological: Collection of stool samples

• Study Type: Observational
• Enrollment (Anticipated): 1160

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland
    • Recruiting
    • The Institute of Bioorganic Chemistry, Polish Academy of Sciences
    • Contact: Email: gmp.mmp@ibch.poznan.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers or oncology patients with primary care clinic

Description

Inclusion Criteria for Healthy Volunteers group:

• Men or women ≥18 years of age
• Patients with informed consent to participate in the study.

Inclusion Criteria for Melanoma group:

• Men or women ≥18 years of age
• Patients with melanoma
• Patients with informed consent to participate in the study.
• Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
• The applied immunotherapy should be the first or second line of treatment.

Exclusion Criteria:

• Patients or Healthy Volunteers who are unable to understand, read and / or sign the informed consent
• Patients or Healthy Volunteers who can not collect stools
• Patients with a fecal transplant
• The applied immunotherapy is not the first or second line of treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; This cohort will consist of 1000 healthy volunteers from Poland.
Melanoma; This cohort will consist of 160 patients with melanoma.	Biological: Collection of stool samples; Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).; Other Names: Atezolizumab; Nivolumab; Ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial diversity in stool samples	Microbial DNA - stool samples sequenced by next-generation sequencing platform.	Inclusion
Eating habits and health survey	It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.	Inclusion

Collaborators and Investigators

• Sponsor: Ardigen
• Collaborators: National Center for Research and Development, Poland; The Institute of Bioorganic Chemistry, Polish Academy of Sciences
• Investigators: Principal Investigator: Anna Philips, PhD, The Institute of Bioorganic Chemistry, Polish Academy of Sciences; Principal Investigator: Jan Majta, Ardigen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Microbiome; Nivolumab; Neoplasms; Immunotherapy; Healthy Volunteers; Melanoma; Ipilimumab; Atezolizumab; Intestinal microbiota; Metagenome; Stool samples
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab; Atezolizumab
• Other Study ID Numbers: MMP; POIR.04.01.02-00-0025/17 (Other Grant/Funding Number: The National Centre for Research and Development)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No