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Clinical Trials/NCT05193305
NCT05193305
Recruiting
Not Applicable

Study of Healthy Cohort for Early Detection of Cancer

Johns Hopkins University1 site in 1 country10,000 target enrollmentFebruary 1, 2023
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Johns Hopkins University
Enrollment
10000
Locations
1
Primary Endpoint
Development of malignancy
Status
Recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
February 28, 2043
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Development of malignancy

Time Frame: Up to 20 years

Assessment of participants for the development of malignancy during a 20-year follow-up period.

Secondary Outcomes

  • Development of biomarkers(Up to 20 years)

Study Sites (1)

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