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NCT03718221 · ClinicalTrials.gov registry record · NA

Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits

A NA study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
NA
Development phase
8,653
Enrollment target

NCT03718221: Completed NA study, sponsored by University of Texas Southwestern Medical Center.

NCT03718221 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 8,653 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (517% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03718221, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
NA
Development phase
8,653 participants
Enrollment target

Study Summary

This is a pragmatic, randomized, controlled trial of a geographically randomized intervention in which all eligible patients will receive a mailed fecal immunochemical test (FIT) kit (the GeoMail study). In this study, all ZIP Codes in Dallas County will be randomized to either treatment or usual care. Patients in treated neighborhoods will receive kits at the same time; patients in usual care neighborhoods will receive FIT kits randomly throughout the year. All eligible patients will receive a FIT kit each year. The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system. This study represents a pragmatic adaptation to the "FIT first" population health screening strategy in which all eligible patients are mailed FIT kits. All patients will also have access to whatever colorectal cancer (CRC) screening is recommended through usual visit-based care.

Primary Outcome

Defined as screening completed within 6 months of when the FIT kit is mailed for each patient by any recommended screening modality (FIT, colonoscopy, sigmoidoscopy; i.e., the proportion of treated vs. usual care patients who have completed screening). Screening will be measured using electronic medical record procedure, result, and billing data (Parkland-specific, CPT, ICD9/10 codes) and will be considered complete when satisfactory (e.g., adequate sample collection) FIT or colonoscopy test res

Interventions

  • OTHER Usual Care FIT Screening Strategy
  • OTHER GeoMail FIT Screening Strategy

Trial Details

FieldValue
Enrollment Target 8,653 participants
Start Date 2018-08-30
Est. Completion 2021-08-30
Phase NA

What the finished NCT03718221 record still lists

NCT03718221 is an interventional study that assigns participants to a tested intervention. Its 8,653 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (517% higher).

The record links to 0 conditions, and to 2 interventions - of which Usual Care FIT Screening Strategy is the first listed.

NCT03718221 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03718221 about?

NCT03718221 is a clinical study titled "Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits". This is a pragmatic, randomized, controlled trial of a geographically randomized intervention in which all eligible patients will receive a mailed fecal immunochemical test (FIT) kit (the GeoMail study). In this study, all ZIP Codes in Dallas County will be randomized to either treatment or usual ca...

What is the current status of trial NCT03718221?

This trial is currently completed. It is a NA study. The enrollment target is 8,653 participants. The study started on 2018-08-30. Estimated completion is 2021-08-30.

What interventions are being tested in trial NCT03718221?

The interventions under investigation include: Usual Care FIT Screening Strategy (OTHER), GeoMail FIT Screening Strategy (OTHER).

Who is sponsoring clinical trial NCT03718221?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03718221's enrollment target sits among peer trials

8,653 18th of 2000 higher than 1,983 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03718221, the US trial registry maintained by the National Library of Medicine. NCT03718221 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.