Lung CarcinomaNCT03340714
Automated Device for Asthma Monitoring and Management in Monitoring Adults With Lung Cancer Undergoing Radiation Therapy
An observational study of Lung Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Monitoring Device
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 25 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic and non-metastatic lung cancer being treated with radiotherapy
Who may be able to join
- Patients are capable of giving informed consent
- Patients are eligible to be treated with RT and plan to start treatment
- Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
- Patients must be able to read or speak English
- Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan
Who cannot join
- Patients who cannot read or speak English
- Patients who are not candidates for RT treatment
- Women of childbearing potential who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study Investigating the Feasibility of ADAMM (Automated Device for Asthma Monitoring and Management) in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Lung Cancer
This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer.
SECONDARY OBJECTIVES:
- Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population
- Conditions
- Lung Carcinoma
- Being tested
- Monitoring Device
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring DeviceDevice
Wear ADAMM
| Study group | Role | What they receive |
|---|---|---|
| Device Feasibility (ADAMM) | Patients wear the Automated Device for Asthma Monitoring and Management (ADAMM) from the time of computed tomography (CT) simulation for radiation therapy (RT) planning throughout the entire RT course and for 4 weeks post-RT Receives: Device: Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Measured: Up to 4 weeks post-radiation therapy
Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Measured: Up to 4 weeks post-radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start20 Mar 2018
- Primary completion25 Oct 2021
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Care Originals, Inc.
- Responsible party
- Sponsor
- Investigators
- Maria Werner-Wasik, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340714
- Sponsor's protocol ID
- 17P.209
- Other IDs
- JT 10294
- Status last verified
- Jan 2024
- First submitted
- 8 Nov 2017
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Feasibility of ADAMM (Automated Device for Asthma Monitoring and Management) in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT03340714
- Acronym / sponsor ID
- 17P.209
- Conditions
- Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Health Care Originals, Inc.
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 13 Nov 2017 (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.
This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.
Detailed description
PRIMARY OBJECTIVES:
- Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer.
SECONDARY OBJECTIVES:
- Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility (ADAMM) | – | Device: Monitoring DevicePatients wear the Automated Device for Asthma Monitoring and Management (ADAMM) from the time of computed tomography (CT) simulation for radiation therapy (RT) planning throughout the entire RT course and for 4 weeks post-RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic and non-metastatic lung cancer being treated with radiotherapy
Key inclusion criteria (5 listed)
- Patients are capable of giving informed consent
- Patients are eligible to be treated with RT and plan to start treatment
- Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
- Patients must be able to read or speak English
- Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan
Key exclusion criteria (3 listed)
- Patients who cannot read or speak English
- Patients who are not candidates for RT treatment
- Women of childbearing potential who are pregnant or breastfeeding
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 |
|---|---|---|
| Monitoring DeviceWear ADAMM | Device | Device Feasibility (ADAMM) |
Primary outcome
Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device
Time frame: Up to 4 weeks post-radiation therapy
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device
Time frame: Up to 4 weeks post-radiation therapy
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Maria Werner-Wasik, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
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 Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device (time frame: Up to 4 weeks post-radiation therapy). The study lists 2 primary outcomes in all. 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 15 May 2025.