NCT06039033

Brief Summary

Taking part in medical research 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 study will admit a wide range of data on the clinical trial experience of Merkel cell carcinoma 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 Merkel cell carcinoma 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
5mo left

Started Oct 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 Progress80%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 8, 2023

Last Update Submit

September 8, 2023

Conditions

Merkel Cell Carcinoma

Keywords

Merkel Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Number of patients who decide to enroll in a Merkel cell carcinoma clinical research

    3 months

  • Rate of patients who remain in Merkel cell carcinoma clinical research 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 Merkel cell carcinoma who are actively considering enrolling in a clinical trial, but have not yet completed enrollment and randomization phases in said clinical trial.

You may qualify if:

  • Aged ≥ 18 years old
  • Able to comprehend the investigational nature of the protocol and provide informed consent
  • Diagnosis of Merkel cell carcinoma

You may not qualify if:

  • No diagnosis of Merkel cell carcinoma confirmed
  • Inability to perform regular electronic reporting
  • Patient does not understand, sign, and return consent form

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)

  • Lambert J, Marrel A, D'Angelo SP, Burgess MA, Chmielowski B, Fazio N, Gambichler T, Grob JJ, Lebbe C, Robert C, Russell J, Guzel G, Bharmal M. Patient Experiences with Avelumab in Treatment-Naive Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.

    PMID: 32472503BACKGROUND

  • Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbe C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3. Epub 2016 Sep 1.

    PMID: 27592805BACKGROUND

  • Topalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbe C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P. Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial. J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.

    PMID: 32324435BACKGROUND

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Condition Hierarchy (Ancestors)

Polyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Michael B Gill

    Power Life Sciences Inc.

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227bask@withpower.com

Study Design

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

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

US(1)