Exploring Merkel Cell Carcinoma Clinical Trial Engagement Patterns
NCT ID: NCT06039033
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
500 participants
OBSERVATIONAL
2024-10-31
2026-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able to comprehend the investigational nature of the protocol and provide informed consent
* Diagnosis of Merkel cell carcinoma
Exclusion Criteria
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
18 Years
ALL
No
Sponsors
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Power Life Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael B Gill
Role: STUDY_DIRECTOR
Power Life Sciences Inc.
Locations
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Power Life Sciences
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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90700326
Identifier Type: -
Identifier Source: org_study_id
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