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Recruiting NCT05193305

Study of Healthy Cohort for Early Detection of Cancer

Observational Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Development of malignancy [Time frame: Up to 20 years]
Secondary outcome measures (1)
  • Development of biomarkers [Time frame: Up to 20 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Johns Hopkins Hospital — Baltimore

Identifiers

NCT: NCT05193305 · IRB00301815

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗