Polish Microbiome Map

Sponsor

Ardigen (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04169867

Collaborator

The Institute of Bioorganic Chemistry, Polish Academy of Sciences (Other), National Center for Research and Development, Poland (Other)

1,160

Enrollment

Location

Anticipated Duration (Months)

32.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Healthy Volunteers Microbiome Metagenome Immunotherapy	Biological: Collection of stool samples

Study Design

Study Type:

Observational

Anticipated Enrollment :

1160 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Polish Microbiome Map

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Jul 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	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: Nivolumab Ipilimumab Atezolizumab

Arm

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:

Nivolumab

Ipilimumab

Atezolizumab

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Institute of Bioorganic Chemistry, Polish Academy of Sciences	Poznań		Poland

Sponsors and Collaborators

Ardigen
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
National Center for Research and Development, Poland

Investigators

Principal Investigator: Anna Philips, PhD, The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Principal Investigator: Jan Majta, Ardigen