- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05780957
Multi-Cancer Early Detection (MCED) of Firefighters
November 3, 2025 updated by: Vincere Cancer Center
This study is an an observational prospective cohort research study to explore the performance of new blood and urine tests for the early detection of cancer among firefighters.
Study Overview
Study Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christine Lau, MD
- Phone Number: 480-306-5390
- Email: drlau@vincerecancer.com
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85260
- Recruiting
- Vincere Cancer Center
-
Principal Investigator:
- Vershalee Shukla, MD
-
Contact:
- Christine Lau, MD
- Phone Number: (480)306-5390
- Email: drlau@vincerecancer.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Actively working firefighters of any adult age, any gender and any demographic group are eligible, as well as no limitations regarding general health status other than those specified in the protocol Eligibility Criteria.
Description
Inclusion Criteria:
- 18 years of age or older
- Currently employed as a firefighter, full-time or part-time
- Taking part in Vincere's First Responder Cancer Screening Program
- Able to donate blood and urine sample
- Able to provide informed consent to participate in the study
Exclusion Criteria:
- Deemed medically unfit for sample donation
- Personal history of cancer in the last 5 years (with the exception of non-melanoma skin cancer)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Firefighters who receive multi-cancer early detection (MCED) test
|
multi-cancer early detection (MCED) test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sensitivity, specificity, positive and negative predictive performance values (PPV and NPV) to detect cancer using Elypta's MCED test, as measured in plasma, in urine, and in plasma and urine combined
Time Frame: Up to 7 years
|
Up to 7 years
|
|
Sensitivity, specificity, positive and negative predictive performance values to detect cancer using Proteotype's MCED test, as measured in plasma.
Time Frame: Up to 2030
|
Up to 2030
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vershalee Shukla, MD, Vincere Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
March 10, 2023
First Submitted That Met QC Criteria
March 10, 2023
First Posted (Actual)
March 23, 2023
Study Record Updates
Last Update Posted (Estimated)
November 5, 2025
Last Update Submitted That Met QC Criteria
November 3, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VCC-MCEDFF-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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