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Trial Title:
Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy
NCT ID:
NCT05937477
Condition:
Lung Cancer
Head and Neck Cancer
Esophageal Cancer
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Fitbit smartwatch
Description:
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.
Arm group label:
Neoadjuvant, Adjuvant Chemotherapy Arm
Arm group label:
Palliative Chemotherapy Arm
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Patients undergoing chemotherapy after being diagnosed with lung, head and neck, or
esophageal cancer.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sehhoon Park
Phone:
+821091858619
Email:
sehhoon.park@samsung.com
Start date:
June 8, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Sehhoon Park
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05937477
