Δευτέρα 30 Δεκεμβρίου 2019

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma: Conditions:   Mesothelioma;   Mesothelioma Malignant;   Mesothelioma; Lung;   Mesotheliomas Pleural;   Mesothelioma Peritoneum;   Mesothelioma; Liver;   Mesothelioma; Omentum Intervention:   Other: No intervention Sponsor:   ProgenaBiome Not yet recruiting (Source: ClinicalTrials.gov)

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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

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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

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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

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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

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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

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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

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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

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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





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