NCT04169867

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

2.6 years

First QC Date

November 18, 2019

Last Update Submit

November 19, 2019

Conditions

MelanomaHealthy VolunteersMicrobiomeMetagenomeImmunotherapy

Keywords

MicrobiomeMelanomaHealthy VolunteersImmunotherapyStool samplesCancerMetagenomeNeoplasmsIntestinal microbiotaNivolumabIpilimumabAtezolizumab

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Interventions

Collection of stool samplesBIOLOGICAL

Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).

Also known as: Nivolumab, Ipilimumab, Atezolizumab
Melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers or oncology patients with primary care clinic

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Institute of Bioorganic Chemistry, Polish Academy of Sciences

Poznan, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

MelanomaNeoplasms

Interventions

NivolumabIpilimumabatezolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anna Philips, PhD

    The Institute of Bioorganic Chemistry, Polish Academy of Sciences

    PRINCIPAL INVESTIGATOR

  • Jan Majta

    Ardigen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Philips, PhD

CONTACT

+48 61 852 89 19gmp.mmp@ibch.poznan.pl

Emilia Strycharz-Angrecka

CONTACT

+48 12 340 94 94emilia.strycharz-angrecka@ardigen.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

January 1, 2018

Primary Completion

July 31, 2020

Study Completion

December 31, 2020

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations

PL(1)