NCT05193305

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
204mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2023Feb 2043

First Submitted

Initial submission to the registry

December 29, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2043

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

5.1 years

First QC Date

December 29, 2021

Last Update Submit

February 24, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Development of malignancy

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

    Up to 20 years

Secondary Outcomes (1)

  • Development of biomarkers

    Up to 20 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective participants who are to undergo upper or lower gastrointestinal endoscopies as part of their normal medical care and deemed necessary by their physicians

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected yearly

Study Officials

  • Elham Afghani

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elham Afghani

CONTACT

410-955-5000eafghan1@jhmi.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 14, 2022

Study Start

February 1, 2023

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2043

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

US(1)