NCT06093594

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 16, 2023

Last Update Submit

October 16, 2023

Conditions

Keywords

Stage IV Melanoma

Outcome Measures

Primary Outcomes (2)

  • Number of stage IV melanoma patients who decide to enroll in a clinical research

    3 months

  • Rate of stage IV melanoma patients who remain in clinical trial to trial completion

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Aged ≥ 18 years old
  • Diagnosis of stage IV melanoma
  • Able to comprehend the investigational nature of the protocol and provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

  • 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.

    PMID: 29580859BACKGROUND
  • 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.

    PMID: 23392854BACKGROUND
  • 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.

    PMID: 26325493BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael B Gill

    Power Life Sciences Inc.

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

November 1, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations