Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy

Lung Cancer Clinical Trial

Official title:

Developing Artificial Intelligence-based Algorism Based on Life-log Data Acquired From Wearable Device for the Prediction of Chemotherapy-induced Side Effects and Symptom

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937477
• Other study ID #: 2023-02-057
• Status: Recruiting
• Start date: June 8, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: Samsung Medical Center
• Contact: Sehhoon Park, MD
• Phone: +82-10-9185-8619
• Email: sehhoon.park[@]samsung.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events.

The investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.

Description:

In this study, patients diagnosed with lung, head and neck, and esophageal cancers and undergoing chemotherapy will be measured for self-reported side effects using a wearable device to collect biomarkers through an app, and the association between patient quality of life and side effects and biomarkers obtained from the wearable device will be analyzed. On the other hand, blood (EDTA 3cc) for pharmacogenomics testing will be tested once at any point during the study period as an indicator associated with side effects after chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 20 years of age or older

• Must have diagnosed with lung, head and neck, or esophageal cancer,

1. scheduled to receive their first treatment in preoperative or postoperative chemotherapy.

2. scheduled for systemic chemotherapy due to recurrence or metastasis.

• Eastern Cooperative Oncology (ECOG) performance status of 0 to 2.

• Patients who have access to a smartphone and can use the mobile app on their own.

• Understand the purpose of the study and agree to participate in the study.

Exclusion Criteria:

• Patients who, in the judgment of the researcher, have difficulty using the application.

• Patients who are judged by the medical staff to be unable to participate in the study.

Related Conditions & MeSH terms

• Esophageal Cancer
• Head and Neck Cancer
• Lung Cancer

Intervention

Other:
• Fitbit smartwatch
Patients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnamgu

Sponsors (1)

Lead Sponsor	Collaborator
Sehhoon Park

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Developing artificial intelligence prediction algorism	PRO data and treatment information collected from the wearable are used to evaluate correlations through methods such as linear regression to determine valid variables, utilizing LSTM models, etc.	Through study completion, an average of 30 months