Study of Healthy Cohort for Early Detection of Cancer

Recruiting

• Conditions: Healthy

• Registration Number: NCT05193305
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-14
• Study Start: 2023-02-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2028-02-28
• Study Completion: 2043-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• All adults 18 years of age of older undergoing upper or lower endoscopy for routine medical care.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of malignancy	Up to 20 years	Assessment of participants for the development of malignancy during a 20-year follow-up period.

Secondary Outcome Measures

Name	Time	Method
Development of biomarkers	Up to 20 years	To identify proteins, RNA and DNA that have changes in expression in those who develop cancer.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States