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NCT07094373 · ClinicalTrials.gov registry record
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
A clinical trial of Chlamydial Infections, sponsored by Sanofi.
- Recruiting
- Registry status
- 533,000
- Enrollment target
- 1
- Study location
NCT07094373: Recruiting study of Chlamydial Infections, sponsored by Sanofi.
NCT07094373 is a study of Chlamydial Infections that is actively recruiting participants, run by Sanofi. The registered enrollment target is 533,000 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07094373, a study of Chlamydial Infections, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- 533,000 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database in the US is an appropriate real-world data (RWD) source for conducting chlamydia-related research to support the chlamydia trachomatis (CT) messenger Ribonucleic acid (mRNA) vaccine program. There are two primary objectives for this study: 1. To determine the validity of ICD, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes to identify patients with chlamydial infections using TriNetX EHR data in the US 2. To describe screening or diagnostic testing and treatment patterns in patients with chlamydia using TriNetX EHR data in the US There are also two secondary objectives for this study: 1. To explore the feasibility of developing a modified algorithm for identifying patients with chlamydia applicable for Merative MarketScan Commercial Claims and Encounters (CCAE) database based on the findings from the primary objectives 2. To compare patient characteristics, use of screening or diagnostic testing, and treatment patterns among patients with chlamydia between TriNetX EHR data and the MarketScan CCAE data in the US
Primary Outcome
Diagnostic performance of ICD-10-CM codes for chlamydial infections, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), compared to Nucleic Acid Amplification Test (NAAT) results for chlamydial infections
Conditions Studied
Study Locations (1)
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 533,000 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2026-06-12 |
What NCT07094373 shows while recruiting
NCT07094373 is an observational study that tracks outcomes without assigning an intervention. Its 533,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Chlamydial Infections appearing as the primary indexed condition, and to 0 interventions.
NCT07094373 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07094373 about?
NCT07094373 is a clinical study titled "Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data". This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database in the US is an appropriate real-world data (RWD) source for conducting...
What is the current status of trial NCT07094373?
This trial is currently recruiting. The enrollment target is 533,000 participants. The study started on 2025-01-01. Estimated completion is 2026-06-12.
What conditions does trial NCT07094373 study?
This clinical trial studies the following conditions: Chlamydial Infections.
Who is sponsoring clinical trial NCT07094373?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07094373 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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