Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma

September 8, 2023 updated by: Memorial Sloan Kettering Cancer Center

Breathprinting (E-Nose) Technology to Measure Response to Treatment of Malignant Pleural Mesothelioma (MPM) Through MPM-Specific Volatile Organic Compounds Detected in Exhalates

The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure how people respond to standard treatment for malignant pleural mesothelioma (MPM). The researchers will study how E-Nose breathprints change over time as people receive standard treatment for MPM. They will also look at how changes in people's E-Nose breathprints compare to changes in their standard imaging scans and in biomarkers of MPM in their blood.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David Jones, MD
  • Phone Number: 212-639-6428

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Consent only)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Consent only)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Consent only )
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Consent only)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All protocol activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Consent Only)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 30-85 years
  • No history of thoracic cancer or extrathoracic cancer potentially involving pleural metastases (i.e., breast, gastric, colon, or pancreas cancer)
  • Recent diagnosis of MPM
  • Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study, and signed standard surgical consent for surgical resection

Exclusion Criteria:

  • Aged <30 or >85 years at the first outpatient visit
  • History of thoracic or extrathoracic cancer that puts the subject at risk for pleural or pulmonary metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-Nose Technology
Patients will undergo E-Nose testing at baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). Patients will undergo E-Nose testing in a presurgical or interventional radiology suite.
Diagnostic test: E-Nose testing
At baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). A breath sample from each patient will be captured in a cartridge, which will form the basis for the E-Nose analysis, to be performed by study investigators at UCB.
Diagnostic test: Research blood
Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of MPMspecific VOCs
Time Frame: up to 1 year
compared with imaging (using RECIST 1.1).
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

UNIVERSITY CAMPUS BIO-MEDICO, ITALY

Investigators

  • Principal Investigator: Gaetano Rocco, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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