Clinical Trials Logo
  1. Home
  2. Mesothelioma
  3. NCT04214015
  4. Details
NCT04214015 Clinical Trial

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

Mesothelioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04214015
Other study ID # PRG-035
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2, 2020
Est. completion date July 2023

Study information
Verified date September 2021
Source ProgenaBiome
Contact Sabine Hazan, MD
Phone 18053390549
Email drsabinehazan@progenabiome.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. 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 2. 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) 3. Diagnosis of metastatic mesothelioma through biopsy and/or advanced imaging Exclusion Criteria: 1. Refusal to sign informed consent form 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. Postoperative stoma, ostomy, or ileoanal pouch 4. Participation in any experimental drug protocol within the past 12 weeks 5. Treatment with total parenteral nutrition

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
There is no intervention for this study

Locations
Country Name City State
United States ProgenaBiome Ventura California

Sponsors (1)
Lead Sponsor Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT06057935 - A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma Phase 2
Terminated NCT02838745 - Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT01912547 - Thromboelastography During Surgery for Malignant Pleural Mesothelioma Phase 0
Completed NCT01521325 - A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers Phase 1
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Recruiting NCT00996385 - Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma Phase 2
Completed NCT02467426 - Isolated Thoracic Perfusion (ITP-F) for MPM Phase 2
Completed NCT00407459 - Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma Phase 2
Completed NCT00787410 - An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma Phase 2
Terminated NCT01907100 - Nintedanib (BIBF 1120) in Mesothelioma Phase 2/Phase 3
Completed NCT04056026 - A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma Early Phase 1
Completed NCT02903914 - Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Terminated NCT03319537 - Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma Phase 1/Phase 2
Terminated NCT03685591 - PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Phase 1