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HomeSearch ResultsStudy Record Detail Save this study
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04214015
Recruitment Status : Not yet recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
See Contacts and Locations
Sponsor:
ProgenaBiome
Information provided by (Responsible Party):
ProgenaBiome
Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Condition or disease Intervention/treatment
Mesothelioma
Mesothelioma Malignant
Mesothelioma; Lung
Mesotheliomas Pleural
Mesothelioma Peritoneum
Mesothelioma; Liver
Mesothelioma; Omentum
Other: No intervention
Detailed Description:
he goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma
Study Design
Go to sections
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Mesothelioma
Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma
U.S. FDA Resources
Groups and Cohorts
Go to sections
Group/Cohort Intervention/treatment
Patients with metastatic mesothelioma
Patients who have been diagnosed with metastatic mesothelioma
Other: No intervention
There is no intervention for this study
Outcome Measures
Go to sections
Primary Outcome Measures :
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [ Time Frame: Three years ]
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with metastatic mesothelioma
Biospecimen Retention: Samples With DNA
Stool samples
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population
Patients with metastatic mesothelioma
Criteria
Inclusion Criteria:
Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
Diagnosis of metastatic mesothelioma through biopsy and/or advanced imaging
Exclusion Criteria:
Refusal to sign informed consent form
History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
Postoperative stoma, ostomy, or ileoanal pouch
Participation in any experimental drug protocol within the past 12 weeks
Treatment with total parenteral nutrition
Contacts and Locations
Go to sections
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): NCT04214015
Contacts
Contact: Sabine Hazan, MD 8053390549 sabinehazan@aim.com
Contact: Jordan Daniels, MS 8053390549 msjordandaniels@gmail.com
Locations
United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome
More Information
Go to sections
Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04214015 History of Changes
Other Study ID Numbers: ProgenaBiome-035
First Posted: December 30, 2019 Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
Hide glossaryGlossary
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms
x
Accepts healthy volunteers
Active comparator arm
Adverse event
Age or age group
All-cause mortality
Allocation
Arm
Arm type
Baseline characteristics
Canceled submission
Certain agreements
Certification
Certification/extension first posted
Certification/extension first submitted
Certification/extension first submitted that met QC criteria
City and distance
Clinical study
Clinical trial
ClinicalTrials.gov identifier (NCT number)
Collaborator
Condition/disease
Contact
Country
Cross-over assignment
Data Monitoring Committee (DMC)
Early Phase 1 (formerly listed as Phase 0)
Eligibility criteria
Enrollment
Exclusion criteria
Expanded access
Expanded access status
Expanded access type
Experimental arm
Extension request
Factorial assignment
First posted
First submitted
First submitted that met QC criteria
Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
Funder type
Gender-based eligibility
Group/cohort
Human subjects protection review board
Inclusion criteria
Informed consent
Informed consent form (ICF)
Intervention model
Intervention/treatment
Interventional study (clinical trial)
Investigator
Last update posted
Last update submitted
Last update submitted that met QC criteria
Last verified
Listed location countries
Location terms
Masking
NCT number
No intervention arm
Observational study
Observational study model
Other adverse event
Other study IDs
Other terms
Outcome measure
Parallel assignment
Participant flow
Patient registry
Phase
Phase 1
Phase 2
Phase 3
Phase 4
Phase Not Applicable
Placebo
Placebo comparator arm
Primary completion date
Primary outcome measure
Primary purpose
Principal investigator (PI)
Protocol
Quality control (QC) review
Randomized allocation
Recruitment status
Registration
Removed location countries
Reporting group
Responsible party
Results database
Results delayed
Results first posted
Results first submitted
Results first submitted that met QC criteria
Results returned after quality control review
Results submitted to ClinicalTrials.gov
Secondary outcome measure
Serious adverse event
Sex
Sham comparator arm
Single group assignment
Sort studies by
Sponsor
State
Statistical analysis plan (SAP)
Status
Study completion date
Study design
Study documents
Study IDs
Study record
Study registry
Study results
Study start date
Study type
Submitted date
Title
Title acronym
U.S. Agency for Healthcare Research and Quality (AHRQ)
U.S. Food and Drug Administration (FDA)
Unknown
Skip to Main Content
ClinicalTrials.gov
Find StudiesFind Studies Menu
About StudiesAbout Studies Menu
Submit StudiesSubmit Studies Menu
ResourcesResources Menu
About SiteAbout Site Menu
HomeSearch ResultsStudy Record Detail Save this study
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04214015
Recruitment Status : Not yet recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
See Contacts and Locations
Sponsor:
ProgenaBiome
Information provided by (Responsible Party):
ProgenaBiome
Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Condition or disease Intervention/treatment
Mesothelioma
Mesothelioma Malignant
Mesothelioma; Lung
Mesotheliomas Pleural
Mesothelioma Peritoneum
Mesothelioma; Liver
Mesothelioma; Omentum
Other: No intervention
Detailed Description:
he goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma
Study Design
Go to sections
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Mesothelioma
Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma
U.S. FDA Resources
Groups and Cohorts
Go to sections
Group/Cohort Intervention/treatment
Patients with metastatic mesothelioma
Patients who have been diagnosed with metastatic mesothelioma
Other: No intervention
There is no intervention for this study
Outcome Measures
Go to sections
Primary Outcome Measures :
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [ Time Frame: Three years ]
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with metastatic mesothelioma
Biospecimen Retention: Samples With DNA
Stool samples
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population
Patients with metastatic mesothelioma
Criteria
Inclusion Criteria:
Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
Diagnosis of metastatic mesothelioma through biopsy and/or advanced imaging
Exclusion Criteria:
Refusal to sign informed consent form
History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
Postoperative stoma, ostomy, or ileoanal pouch
Participation in any experimental drug protocol within the past 12 weeks
Treatment with total parenteral nutrition
Contacts and Locations
Go to sections
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): NCT04214015
Contacts
Contact: Sabine Hazan, MD 8053390549 sabinehazan@aim.com
Contact: Jordan Daniels, MS 8053390549 msjordandaniels@gmail.com
Locations
United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome
More Information
Go to sections
Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04214015 History of Changes
Other Study ID Numbers: ProgenaBiome-035
First Posted: December 30, 2019 Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
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