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
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Healthy

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