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Polish Microbiome Map

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169867
Recruitment Status : Unknown
Verified November 2019 by Ardigen.
Recruitment status was:  Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
National Center for Research and Development, Poland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Melanoma Healthy Volunteers Microbiome Metagenome Immunotherapy Biological: Collection of stool samples

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Study Type : Observational
Estimated Enrollment : 1160 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Polish Microbiome Map
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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:
  • Nivolumab
  • Ipilimumab
  • Atezolizumab




Primary Outcome Measures :
  1. Microbial diversity in stool samples [ Time Frame: Inclusion ]
    Microbial DNA - stool samples sequenced by next-generation sequencing platform.

  2. Eating habits and health survey [ Time Frame: Inclusion ]
    It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.


Biospecimen Retention:   Samples With DNA
Stool samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers or oncology patients with primary care clinic
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169867


Contacts
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Contact: Anna Philips, PhD +48 61 852 89 19 gmp.mmp@ibch.poznan.pl
Contact: Emilia Strycharz-Angrecka +48 12 340 94 94 emilia.strycharz-angrecka@ardigen.com

Locations
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Poland
The Institute of Bioorganic Chemistry, Polish Academy of Sciences Recruiting
Poznań, Poland
Contact       gmp.mmp@ibch.poznan.pl   
Sponsors and Collaborators
Ardigen
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
National Center for Research and Development, Poland
Investigators
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Principal Investigator: Anna Philips, PhD The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Principal Investigator: Jan Majta Ardigen
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Responsible Party: Ardigen
ClinicalTrials.gov Identifier: NCT04169867    
Other Study ID Numbers: MMP
POIR.04.01.02-00-0025/17 ( Other Grant/Funding Number: The National Centre for Research and Development )
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ardigen:
Microbiome
Melanoma
Healthy Volunteers
Immunotherapy
Stool samples
Cancer
Metagenome
Neoplasms
Intestinal microbiota
Nivolumab
Ipilimumab
Atezolizumab
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Ipilimumab
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action