Lung CancerNCT05760170
Determining Clinical Trial Experiences of Lung Cancer Patients
An observational study of Lung Cancer, run by Power Life Sciences Inc..
Trial summary
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2026
- 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: Lung cancer patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- Patient has been diagnosed with lung cancer
- Patient has self-identified as planning to enroll in an observational clinical trial
- Patient is a minimum of 18 years or older
Who cannot join
- Pregnant or nursing patients
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Observational Study to Determine Experience Patterns in Participants of Lung Cancer Clinical Trials
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This trial will admit a wide range of data on the clinical trial experience of lung cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future lung cancer patients.
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lung cancer patients who decide to enroll in a clinical trial
Measured: 3 months
Rate of patients who remain in a lung cancer clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760170
- Sponsor's protocol ID
- 81893664
- Status last verified
- Jun 2023
- First submitted
- 25 Feb 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Menis J, Besse B, Lacombe D. Methodology of clinical trials in lung cancer. Chin Clin Oncol. 2015 Dec;4(4):44. doi: 10.3978/j.issn.2304-3865.2015.11.03.
PubMed 26730756Schulkes KJ, Nguyen C, van den Bos F, van Elden LJ, Hamaker ME. Selection of Patients in Ongoing Clinical Trials on Lung Cancer. Lung. 2016 Dec;194(6):967-974. doi: 10.1007/s00408-016-9943-7. Epub 2016 Sep 20.
PubMed 27650509Schulkes KJ, Nguyen C, van den Bos F, Hamaker ME, van Elden LJ. Patient-Centered Outcome Measures in Lung Cancer Trials. Lung. 2016 Aug;194(4):647-52. doi: 10.1007/s00408-016-9903-2. Epub 2016 Jun 10.
PubMed 27287676
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine Experience Patterns in Participants of Lung Cancer Clinical Trials
- ClinicalTrials.gov ID
- NCT05760170
- Acronym / sponsor ID
- 81893664
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 8 Mar 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.
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This trial will admit a wide range of data on the clinical trial experience of lung cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future lung cancer patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Patient has been diagnosed with lung cancer
- Patient has self-identified as planning to enroll in an observational clinical trial
- Patient is a minimum of 18 years or older
Key exclusion criteria (3 listed)
- Pregnant or nursing patients
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of lung cancer patients who decide to enroll in a clinical trial
Time frame: 3 months
Rate of patients who remain in a lung cancer clinical trial to trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 26730756Menis J, Besse B, Lacombe D. Methodology of clinical trials in lung cancer. Chin Clin Oncol. 2015 Dec;4(4):44. doi: 10.3978/j.issn.2304-3865.2015.11.03.
- Background: PubMed 27650509Schulkes KJ, Nguyen C, van den Bos F, van Elden LJ, Hamaker ME. Selection of Patients in Ongoing Clinical Trials on Lung Cancer. Lung. 2016 Dec;194(6):967-974. doi: 10.1007/s00408-016-9943-7. Epub 2016 Sep 20.
- Background: PubMed 27287676Schulkes KJ, Nguyen C, van den Bos F, Hamaker ME, van Elden LJ. Patient-Centered Outcome Measures in Lung Cancer Trials. Lung. 2016 Aug;194(4):647-52. doi: 10.1007/s00408-016-9903-2. Epub 2016 Jun 10.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Power Life Sciences Inc..
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 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lung cancer patients who decide to enroll in a clinical trial (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05760170, which also lists 3 linked publications.
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 5 Jun 2023.