Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorSehhoon Park
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
20 years of age or older
Must have diagnosed with lung, head and neck, or esophageal cancer,
scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
scheduled for systemic chemotherapy due to recurrence or metastasis.
Disqualifiers
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.
Trial population
Patients undergoing chemotherapy after being diagnosed with lung, head and neck, or esophageal cancer.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Fitbit smartwatch
Other interventionPatients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Neoadjuvant, Adjuvant Chemotherapy Arm1 intervention
Group B: Palliative Chemotherapy Arm1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sehhoon Park
Lead sponsor
Samsung Medical Center
Sponsor institution
Source ClinicalTrials.gov