Observational study to evaluate the capability of digital devices to detect drug-induced interstitial pneumonia caused by cancer drug therapy

Observational study to evaluate the capability of digital devices to detect drug-induced interstitial pneumonia caused by cancer drug therapy - Observational study using digital devices for drug-induced interstitial pneumonia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055894

Enrollment

Registered

2024-10-21

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with drug-induced interstitial pneumonia caused by cancer drug therapy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are at least 18 years of age at the time of informed consent 2) Patients diagnosed with cancer 3) Patients with drug-induced interstitial pneumonia caused by cancer drug therapy 4) Patients who the investigators determine that patients or their caregivers can use the digital devices* for measurements in the study 5) Patients who provided informed consent to participate in the study *Android smart phone for the study, abnormal respiratory sounds detection device

Exclusion criteria

Exclusion criteria: 1) Patients who are determined by the investigators to be ineligible because of psychological disorders that may affect the use of the digital devices* in the study 2) Patients who are determined by the investigators to have respiratory complications** that may affect the measurement results of the digital devices* in the study 3) Patients who are scheduled to travel overseas during participation in the study 4) Patients who are determined by the investigators to be ineligible for participate in the study for any reason *Android smart phone for the study, abnormal respiratory sounds detection device **Respiratory diseases that produce fine crackles, such as pulmonary fibrosis and mycoplasma pneumonia

Design outcomes

Primary

Measure	Time frame
Sensitivity of digital devices to fine crackles	—

Secondary

Measure	Time frame
- Positive predictive value of digital devices to fine crackles - Sensitivity of digital devices to adventitious sound - Positive predictive value of digital devices to adventitious sound - Percentage of concordance between the results of the detection of adventitious sound by a respiratory specialist obtained by the researcher and those obtained by the patients or their care giver - Percentage of concordance between the results of the detection of adventitious sound by digital devices obtained by the researcher and those obtained by the patients or their care giver	—

Measure

Time frame

- Positive predictive value of digital devices to fine crackles - Sensitivity of digital devices to adventitious sound - Positive predictive value of digital devices to adventitious sound - Percentage of concordance between the results of the detection of adventitious sound by a respiratory specialist obtained by the researcher and those obtained by the patients or their care giver - Percentage of concordance between the results of the detection of adventitious sound by digital devices obtained by the researcher and those obtained by the patients or their care giver

—

Countries

Japan

Contacts

Public ContactYuta Suzuki

Mebix, Inc. Clinical Operations

ild-samd_pilot@mebix.co.jp03-4362-4500

Outcome results