Bruk av e-neseteknologi for å måle respons på behandling hos personer med ondartet pleural mesothelioma
Breathprinting (E-Nose) teknologi for å måle respons på behandling av ondartet pleural mesothelioma (MPM) gjennom MPM-spesifikke flyktige organiske forbindelser oppdaget i utåndinger
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: David Jones, MD
- Telefonnummer: 212-639-6428
Studer Kontakt Backup
- Navn: Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
- E-post: roccog@mskcc.org
Studiesteder
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New Jersey
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Basking Ridge, New Jersey, Forente stater, 07920
- Rekruttering
- Memorial Sloan Kettering Basking Ridge (Consent Only)
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Ta kontakt med:
- Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
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Middletown, New Jersey, Forente stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Consent Only)
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Ta kontakt med:
- Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
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Montvale, New Jersey, Forente stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Consent Only )
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Ta kontakt med:
- Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
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New York
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Commack, New York, Forente stater, 11725
- Rekruttering
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)
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Ta kontakt med:
- Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
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Harrison, New York, Forente stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Consent Only)
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Ta kontakt med:
- Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Ta kontakt med:
- Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
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Uniondale, New York, Forente stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Consent Only)
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Ta kontakt med:
- Gaetano Rocco, MD
- Telefonnummer: 212-639-3478
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: E-Nose Technology
Patients undergo a breathprinting test (E-Nose) at baseline and at the first three standard of care follow-ups, as scheduled by their treating physician, that involve a CT of the Chest and/or PET/CT. The E-Nose testing will be administered by trained staff. Staff will use proper personal protective equipment during collections. Subjects will undergo E-Nose testing in a presurgical or interventional radiology suite. Subjects must consent to no smoking, no tooth brushing, and no food or drinks starting on midnight of the day of the E-Nose test. If fasting from midnight until the E-Nose test is not feasible, subjects may consent to fasting for 2 hours prior to each E-Nose test. Subjects opting to fast for 2 hours before each E-Nose test can only have still, non-carbonated water and non-aromatic foods or foods that do not develop aromatic compounds, such as low salt simple crackers, starting at midnight on the day of the E-Nose test until 2 hours before the collection. |
At baseline (before any treatment is administered) approximately when the patient is scheduled for a CT of the Chest and/or PET/CT after initiation of any treatment, as medically permissible and at the PI's discretion. 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. Research blood tests will be obtained at baseline and the first three standard of care follow up visits, scheduled by their treating physician along with a CT of the Chest and/or PET/CT1 to determine whether serum biomarkers of MPM. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change of MPMspecific VOCs
Tidsramme: up to 1 year
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compared with imaging (using RECIST 1.1 and mRECIST). |
up to 1 year
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Gaetano Rocco, MD, Memorial Sloan Kettering Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 23-100
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
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