Stage IV MelanomaNCT06093594
Investigating Participation Patterns Among Stage IV Melanoma Patients
An observational study of Stage IV Melanoma, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Clinical trials, specifically focused on stage IV melanoma, are crucial in assessing the safety and efficacy of new treatments for this disease. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Melanoma
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 stage IV melanoma who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.
Who may be able to join
- Aged ≥ 18 years old
- Diagnosis of stage IV melanoma
- Able to comprehend the investigational nature of the protocol and provide informed consent
Who cannot join
- Female patients who are currently pregnant or nursing
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Inability to perform regular electronic reporting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Understanding Patient Engagement Trends in Stage IV Melanoma Clinical Trials
Clinical trials, specifically focused on stage IV melanoma, are crucial in assessing the safety and efficacy of new treatments for this disease. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.
The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.
- Conditions
- Stage IV Melanoma
- Keywords
- Stage IV Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stage IV melanoma patients who decide to enroll in a clinical research
Measured: 3 months
Rate of stage IV melanoma patients who remain in 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 posted23 Oct 2023
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 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 Stage IV MelanomaStudies 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
- NCT06093594
- Sponsor's protocol ID
- 74815433
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scott JF, Conic RZ, Thompson CL, Gerstenblith MR, Bordeaux JS. Stage IV melanoma of unknown primary: A population-based study in the United States from 1973 to 2014. J Am Acad Dermatol. 2018 Aug;79(2):258-265.e4. doi: 10.1016/j.jaad.2018.03.021. Epub 2018 Mar 23.
PubMed 29580859Wevers KP, Hoekstra HJ. Stage IV melanoma: completely resectable patients are scarce. Ann Surg Oncol. 2013 Jul;20(7):2352-6. doi: 10.1245/s10434-013-2881-1. Epub 2013 Feb 8.
PubMed 23392854Luen S, Wong SW, Mar V, Kelly JW, McLean C, McArthur GA, Haydon A. Primary Tumor Thickness is a Prognostic Factor in Stage IV Melanoma: A Retrospective Study of Primary Tumor Characteristics. Am J Clin Oncol. 2018 Jan;41(1):90-94. doi: 10.1097/COC.0000000000000226.
PubMed 26325493
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patient Engagement Trends in Stage IV Melanoma Clinical Trials
- ClinicalTrials.gov ID
- NCT06093594
- Acronym / sponsor ID
- 74815433
- Conditions
- Stage IV Melanoma
- Keywords
- Stage IV Melanoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Oct 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 trials, specifically focused on stage IV melanoma, are crucial in assessing the safety and efficacy of new treatments for this disease. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.
The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of 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
- Patients with stage IV melanoma who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Aged ≥ 18 years old
- Diagnosis of stage IV melanoma
- Able to comprehend the investigational nature of the protocol and provide informed consent
Key exclusion criteria (3 listed)
- Female patients who are currently pregnant or nursing
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Inability to perform regular electronic reporting
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 stage IV melanoma patients who decide to enroll in a clinical research
Time frame: 3 months
Rate of stage IV melanoma patients who remain in clinical trial to trial completion
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 29580859Scott JF, Conic RZ, Thompson CL, Gerstenblith MR, Bordeaux JS. Stage IV melanoma of unknown primary: A population-based study in the United States from 1973 to 2014. J Am Acad Dermatol. 2018 Aug;79(2):258-265.e4. doi: 10.1016/j.jaad.2018.03.021. Epub 2018 Mar 23.
- Background: PubMed 23392854Wevers KP, Hoekstra HJ. Stage IV melanoma: completely resectable patients are scarce. Ann Surg Oncol. 2013 Jul;20(7):2352-6. doi: 10.1245/s10434-013-2881-1. Epub 2013 Feb 8.
- Background: PubMed 26325493Luen S, Wong SW, Mar V, Kelly JW, McLean C, McArthur GA, Haydon A. Primary Tumor Thickness is a Prognostic Factor in Stage IV Melanoma: A Retrospective Study of Primary Tumor Characteristics. Am J Clin Oncol. 2018 Jan;41(1):90-94. doi: 10.1097/COC.0000000000000226.
- 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.
Michael B Gill study director
Power Life Sciences Inc.
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 Stage IV Melanoma, run by Power Life Sciences Inc. 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 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: opening soon, as of the sponsor's last update on 23 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of stage IV melanoma patients who decide to enroll in a clinical research (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 NCT06093594, 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 23 Oct 2023.