Lung CancerNCT05937477
Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy
An observational study of Lung Cancer and Head and Neck Cancer, run by Sehhoon Park at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer, Head and Neck Cancer, Esophageal Cancer
- What is being tested?
- Fitbit smartwatch
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2023to 30 Jun 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing chemotherapy after being diagnosed with lung, head and neck, or esophageal cancer.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnamgu, 06351
Sehhoon Park, +821091858619, sehhoon.park@samsung.com
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer, Head and Neck Cancer, Esophageal Cancer
- Being tested
- Fitbit smartwatch
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit smartwatchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant, Adjuvant Chemotherapy Arm | Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Neoadjuvant, Adjuvant chemotherapy. Receives: Other: Fitbit smartwatch | |
| Palliative Chemotherapy Arm | Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Palliative chemotherapy. Receives: Other: Fitbit smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start8 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sehhoon Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sehhoon Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937477
- Sponsor's protocol ID
- 2023-02-057
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05937477
- Acronym / sponsor ID
- 2023-02-057
- Conditions
- Lung Cancer, Head and Neck Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sehhoon ParkUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant, Adjuvant Chemotherapy Arm | – | Other: Fitbit smartwatchPatients diagnosed with lung, head and neck, or esophageal cancer and undergoing Neoadjuvant, Adjuvant chemotherapy. |
| Palliative Chemotherapy Arm | – | Other: Fitbit smartwatchPatients diagnosed with lung, head and neck, or esophageal cancer and undergoing Palliative chemotherapy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing chemotherapy after being diagnosed with lung, head and neck, or esophageal cancer.
Key inclusion criteria (7 listed)
- 20 years of age or older
- Must have diagnosed with lung, head and neck, or esophageal cancer,
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit smartwatchPatients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals. | Other | Neoadjuvant, Adjuvant Chemotherapy Arm, Palliative Chemotherapy Arm |
Primary outcome
Developing artificial intelligence prediction algorism
Time frame: Through study completion, an average of 30 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Head and Neck Cancer, run by Sehhoon Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sehhoon Park, MD (+82-10-9185-8619, sehhoon.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing artificial intelligence prediction algorism (time frame: Through study completion, an average of 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023; AzTrials last refreshed its copy on 3 Nov 2026.