MelanomaNCT04169867
Polish Microbiome Map
An observational study of Melanoma and Healthy Volunteers, run by Ardigen at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Healthy Volunteers, Microbiome
- What is being tested?
- Collection of stool samples
- How many people
- 1,160 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers or oncology patients with primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Poznan
gmp.mmp@ibch.poznan.pl
About this study
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.
- Conditions
- Melanoma, Healthy Volunteers, Microbiome, Metagenome, Immunotherapy
- Being tested
- Collection of stool samples
- Keywords
- Microbiome, Melanoma, Healthy Volunteers, Immunotherapy, Stool samples, Cancer, Metagenome, Neoplasms, Intestinal microbiota, Nivolumab, Ipilimumab, Atezolizumab
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of stool samplesBiological
Also called Nivolumab, Ipilimumab, Atezolizumab
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | This cohort will consist of 1000 healthy volunteers from Poland. | |
| Melanoma | This cohort will consist of 160 patients with melanoma. Receives: Biological: Collection of stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial diversity in stool samples
Microbial DNA - stool samples sequenced by next-generation sequencing platform.
Measured: Inclusion
Eating habits and health survey
It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Jan 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardigen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Institute of Bioorganic Chemistry, Polish Academy of Sciences, National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Anna Philips, PhD, Principal investigator, The Institute of Bioorganic Chemistry, Polish Academy of SciencesJan Majta, Principal investigator, Ardigen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169867
- Sponsor's protocol ID
- MMP
- Other IDs
- POIR.04.01.02-00-0025/17
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Microbiome Map
- ClinicalTrials.gov ID
- NCT04169867
- Acronym / sponsor ID
- MMP
- Conditions
- Melanoma, Healthy Volunteers, Microbiome, Metagenome, Immunotherapy
- Keywords
- Microbiome, Melanoma, Healthy Volunteers, Immunotherapy, Stool samples, Cancer, Metagenome, Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- ArdigenIndustry (pharma, biotech, devices)
- Collaborators
- The Institute of Bioorganic Chemistry, Polish Academy of Sciences, National Center for Research and Development, Poland
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –This cohort will consist of 1000 healthy volunteers from Poland. |
| Melanoma | – | Biological: Collection of stool samplesThis cohort will consist of 160 patients with melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers or oncology patients with primary care clinic
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of stool samplesAlso: Nivolumab, Ipilimumab, AtezolizumabPatients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ). | Biological | Melanoma |
Primary outcome
Microbial diversity in stool samples
Time frame: Inclusion
Microbial DNA - stool samples sequenced by next-generation sequencing platform.
Eating habits and health survey
Time frame: Inclusion
It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Philips, PhD principal investigator
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Jan Majta principal investigator
Ardigen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Healthy Volunteers, run by Ardigen at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Philips, PhD (+48 61 852 89 19, gmp.mmp@ibch.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial diversity in stool samples (time frame: Inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.