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

NCT04214015 | Withdrawn DMC

• 1 other identifier: PRG-035
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Conditions

Mesothelioma; Mesothelioma Malignant; Mesothelioma; Lung; Mesotheliomas Pleural; Mesothelioma Peritoneum; Mesothelioma; Liver; Mesothelioma; Omentum

Outcome Measures

Primary Outcomes (1)

• Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

  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

  Three years

Study Arms (1)

Patients with metastatic mesothelioma

Patients who have been diagnosed with metastatic mesothelioma

Other: No intervention

Interventions

No intervention OTHER

There is no intervention for this study

Patients with metastatic mesothelioma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic mesothelioma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Mesothelioma; Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: December 30, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)