Small Cell Lung CancerNCT05769504
Examining Clinical Trial Participation for Small Cell Lung Cancer Patients
An observational study of Small Cell Lung Cancer, run by Power Life Sciences Inc..
Trial summary
Clinical study participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 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: Small cell lung cancer patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.
Who may be able to join
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Participant has a diagnosis of small cell lung cancer.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
Who cannot join
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
- Pregnant or lactating woman
- Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Studying Patient Experiences in Small Cell Lung Cancer Clinical Trials to Identify Influencing Factors
Clinical study participation percentages haven't always been fully representative of a given demographic.
The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.
The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future small cell lung cancer patients during clinical trials.
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a small cell lung cancer clinical study.
Measured: 3 months
Number of small cell lung cancer patients who remain in clinical trial until 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 posted15 Mar 2023
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 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 Small Cell 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
- NCT05769504
- Sponsor's protocol ID
- 86382894
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Meerbeeck JP, Fennell DA, De Ruysscher DK. Small-cell lung cancer. Lancet. 2011 Nov 12;378(9804):1741-55. doi: 10.1016/S0140-6736(11)60165-7. Epub 2011 May 10.
PubMed 21565397Seto Z, Takata N, Murayama N, Tokui K, Okazawa S, Kambara K, Imanishi S, Miwa T, Hayashi R, Matsui S, Inomata M. Irinotecan monotherapy as third- or further-line treatment for patients with small cell lung cancer. Tumori. 2021 Dec;107(6):536-541. doi: 10.1177/0300891620974762. Epub 2020 Nov 25.
PubMed 34847814Xing H, Zhang J, Ge F, Yu X, Bian H, Zhang F, Fang J. [Analysis of the Efficacy of Irinotecan in the Second-line Treatment of Refractory and Relapsed Small Cell Lung Cancer]. Zhongguo Fei Ai Za Zhi. 2021 Mar 20;24(3):167-172. doi: 10.3779/j.issn.1009-3419.2021.103.04. Chinese.
PubMed 33819966
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Patient Experiences in Small Cell Lung Cancer Clinical Trials to Identify Influencing Factors
- ClinicalTrials.gov ID
- NCT05769504
- Acronym / sponsor ID
- 86382894
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell 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
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 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.
Clinical study participation percentages haven't always been fully representative of a given demographic.
The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.
The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future small cell lung cancer patients during clinical trials.
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
- Small cell lung cancer patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.
Key inclusion criteria (3 listed)
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Participant has a diagnosis of small cell lung cancer.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
Key exclusion criteria (3 listed)
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
- Pregnant or lactating woman
- Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
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
Rate of patients who decide to enroll in a small cell lung cancer clinical study.
Time frame: 3 months
Number of small cell lung cancer patients who remain in clinical trial until 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 3 Apr 2023.
- Background: PubMed 21565397van Meerbeeck JP, Fennell DA, De Ruysscher DK. Small-cell lung cancer. Lancet. 2011 Nov 12;378(9804):1741-55. doi: 10.1016/S0140-6736(11)60165-7. Epub 2011 May 10.
- Background: PubMed 34847814Seto Z, Takata N, Murayama N, Tokui K, Okazawa S, Kambara K, Imanishi S, Miwa T, Hayashi R, Matsui S, Inomata M. Irinotecan monotherapy as third- or further-line treatment for patients with small cell lung cancer. Tumori. 2021 Dec;107(6):536-541. doi: 10.1177/0300891620974762. Epub 2020 Nov 25.
- Background: PubMed 33819966Xing H, Zhang J, Ge F, Yu X, Bian H, Zhang F, Fang J. [Analysis of the Efficacy of Irinotecan in the Second-line Treatment of Refractory and Relapsed Small Cell Lung Cancer]. Zhongguo Fei Ai Za Zhi. 2021 Mar 20;24(3):167-172. doi: 10.3779/j.issn.1009-3419.2021.103.04. Chinese.
- 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 Small Cell 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 3 Apr 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 (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a small cell lung cancer clinical study. (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 NCT05769504, 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 3 Apr 2023.