Biomedical Signal Extraction From Symptom Descriptions: An Observational Registry Using the OpenGenome Platform (OGNOME-REG)

May 16, 2026 updated by: OpenGenome

Accuracy and Calibration of Evidence-Grounded Biomedical Signal Extraction From Free-Text Symptom Descriptions: A Prospective Observational Registry Using the OpenGenome Automated Research Instrument

This registry prospectively collects anonymized free-text symptom descriptions submitted voluntarily by adults through the OpenGenome platform at opengenome.bio. For each submission, the system retrieves real biomedical literature from PubMed and ClinicalTrials.gov in parallel, applies a constrained reasoning model operating under a strict output schema, and returns a structured biological signal report. The study evaluates the internal consistency of extracted signals, the calibration of confidence scores relative to dataset size and symptom specificity, and the distribution of biological signal categories across a large anonymous population. No intervention is assigned. No participant contact occurs. All data is anonymized at the point of collection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OpenGenome is a publicly accessible, anonymous research instrument that maps free-text symptom descriptions to structured biological signals grounded in primary biomedical literature. Upon submission, the platform dispatches parallel queries to PubMed via NCBI E-utilities and ClinicalTrials.gov v2 API, retrieving up to 16 real sources per submission. A reasoning model constrained by a strict schema extracts a primary biological signal, up to five secondary signals, a plain-language correlation explanation, a confidence score, and a signal strength score. All scores are integers on a 0 to 100 scale. Sources are included by PMID or NCT identifier and are directly linkable for independent verification. This registry will analyze aggregate anonymized outputs to characterize signal consistency, score calibration, and population-level signal distributions.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • State of Berlin
      • Friedrichshain, State of Berlin, Germany, 10243
        • Recruiting
        • OpenGenome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adults aged 18 years or older who voluntarily access the OpenGenome platform at opengenome.bio and submit a free-text description of symptoms or health-related observations for automated biomedical signal analysis.

Description

  • Automated or programmatically generated submissions detected by rate limiting
  • Submissions containing no discernible symptom or health-related content

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Voluntary Submitters
Adults aged 18 or older who voluntarily submit a free-text symptom description via the OpenGenome platform and receive a structured biological signal report. No intervention is assigned.
Other: OpenGenome AI Platform
AI-assisted biomedical signal extraction from free-text symptom descriptions, cross-referenced against PubMed and ClinicalTrials.gov evidence sources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal signal-source concordance rate
Time Frame: At point of automated report generation, assessed continuously over 12 months
Proportion of primary signal claims in generated reports that are traceable to at least one retrieved PubMed or ClinicalTrials.gov source included in the same report
At point of automated report generation, assessed continuously over 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OpenGenome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2026

Primary Completion (Estimated)

May 5, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGNOME-OBS-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data is not available as all submissions are fully anonymous with no participant identifiers collected. Aggregate deidentified summary statistics will be made available upon study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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