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NCT05193305 Clinical Trial

Study of Healthy Cohort for Early Detection of Cancer

Healthy Clinical Trial

Official title:
Study of Healthy Cohort for Early Detection of Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05193305
Other study ID # IRB00301815
Secondary ID 5P50CA062924
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 28, 2043

Study information
Verified date February 2024
Source Johns Hopkins University
Contact Elham Afghani
Phone 410-955-5000
Email eafghan1@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cancer produces a significant burden on society with a majority diagnosed at late stages when the chance of cure is low. Early diagnosis improves patient outcomes. Data consisting of lifestyle factors, medications, physical activity, years before conventional cancer diagnosis is also worthwhile for to determine early detection. This is only achievable with longitudinal tracking of a large number of healthy individuals and identifying those who do develop cancer over time.

Description:

To conduct a longitudinal cohort study of patients who do not have a malignancy at the time of enrollment and are followed over a 20 year period to see if patients develop a malignancy and associate clinical and lifestyle factors as well as collection of blood. All adults 18 years of age and older undergoing upper or lower endoscopy for routine medical care will be eligible for this study.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date February 28, 2043
Est. primary completion date February 28, 2028
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adults 18 years of age of older undergoing upper or lower endoscopy for routine medical care. Exclusion Criteria: - Persons with current malignancy - Persons with history of malignancy and treatment within last 5 years of enrollment, excluding non-melanoma skin cancer or cervical in-situ. - Persons who are unable or unwilling to provide repeat blood samples and complete follow-up questionnaires - Persons who lack the capacity to provide consent - Persons who do not speak English - Persons who are visually or hearing impaired.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of malignancy Assessment of participants for the development of malignancy during a 20-year follow-up period. Up to 20 years
Secondary Development of biomarkers To identify proteins, RNA and DNA that have changes in expression in those who develop cancer. Up to 20 years
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