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

Primary Purpose

Malignant Pleural Mesothelioma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-Nose testing
Research blood
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Pleural Mesothelioma focused on measuring Breathprinting (E-Nose) Technology, MPM-Specific Volatile Organic Compounds, 23-100

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Consent Only)Recruiting
  • Memorial Sloan Kettering Monmouth (Consent Only)Recruiting
  • Memorial Sloan Kettering Bergen (Consent Only )Recruiting
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)Recruiting
  • Memorial Sloan Kettering Westchester (Consent Only)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Consent Only)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E-Nose Technology

Arm Description

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.

Outcomes

Primary Outcome Measures

Change of MPMspecific VOCs
compared with imaging (using RECIST 1.1).

Secondary Outcome Measures

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
UNIVERSITY CAMPUS BIO-MEDICO, ITALY
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1. Study Identification

Unique Protocol Identification Number
NCT06037941
Brief Title
Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma
Official Title
Breathprinting (E-Nose) Technology to Measure Response to Treatment of Malignant Pleural Mesothelioma (MPM) Through MPM-Specific Volatile Organic Compounds Detected in Exhalates
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
UNIVERSITY CAMPUS BIO-MEDICO, ITALY

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
Keywords
Breathprinting (E-Nose) Technology, MPM-Specific Volatile Organic Compounds, 23-100

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-Nose Technology
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
E-Nose testing
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Research blood
Intervention Description
Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.
Primary Outcome Measure Information:
Title
Change of MPMspecific VOCs
Description
compared with imaging (using RECIST 1.1).
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Rocco, MD
Phone
212-639-3478
Email
roccog@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Jones, MD
Phone
212-639-6428
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent Only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Phone
212-639-3478
Facility Name
Memorial Sloan Kettering Monmouth (Consent Only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Phone
212-639-3478
Facility Name
Memorial Sloan Kettering Bergen (Consent Only )
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Phone
212-639-3478
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Phone
212-639-3478
Facility Name
Memorial Sloan Kettering Westchester (Consent Only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Phone
212-639-3478
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Phone
212-639-3478
Facility Name
Memorial Sloan Kettering Nassau (Consent Only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Rocco, MD
Phone
212-639-3478

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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