Polish Microbiome Map

• Conditions: Melanoma; Healthy Volunteers; Immunotherapy; Microbiome; Metagenome
• Interventions: Biological: Collection of stool samples

• Registration Number: NCT04169867
• Lead Sponsor: Ardigen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1160

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Melanoma	Collection of stool samples	This cohort will consist of 160 patients with melanoma.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Institute of Bioorganic Chemistry, Polish Academy of Sciences; 🇵🇱 Poznań, Poland