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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06093594
Other study ID # 74815433
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2024
Est. completion date November 2026

Study information

Verified date October 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 415-900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 implementation. The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date November 2026
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged = 18 years old - Diagnosis of stage IV melanoma - Able to comprehend the investigational nature of the protocol and provide informed consent Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Luen 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. — View Citation

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. — View Citation

Wevers 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of stage IV melanoma patients who decide to enroll in a clinical research 3 months
Primary Rate of stage IV melanoma patients who remain in clinical trial to trial completion 12 months
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