Polish Microbiome Map

Ardigen

Status: Unknown

Conditions: Healthy Volunteers; Melanoma; Immunotherapy; Microbiome; Metagenome

Treatments: Biological: Collection of stool samples

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04169867

MMP

POIR.04.01.02-00-0025/17 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 1,160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,160 participants in 2 patient groups

Healthy Volunteers

Description:

This cohort will consist of 1000 healthy volunteers from Poland.

Melanoma

Description:

This cohort will consist of 160 patients with melanoma.

Treatment:

Biological: Collection of stool samples