Signs and SymptomsOGNOME-REGNCT07578610
Biomedical Signal Extraction From Symptom Descriptions: An Observational Registry Using the OpenGenome Platform
An observational study of Signs and Symptoms and Fever, run by OpenGenome at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Fever, Myalgia
- What is being tested?
- OpenGenome AI Platform
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 5 May 2026to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
- Automated or programmatically generated submissions detected by rate limiting
- Submissions containing no discernible symptom or health-related content
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
OpenGenome
Friedrichshain, State of Berlin, 10243
About this study
Official title: 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.
Read the 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.
- Conditions
- Signs and Symptoms, Fever, Myalgia, Skin Diseases, Hemorrhagic Fever With Renal Syndrome, Zoonoses
- Being tested
- OpenGenome AI Platform
- Keywords
- biomedical signal extraction, symptom analysis, PubMed
- Medical subject headings
- Signs and Symptoms, Fever, Myalgia, Skin Diseases, Hemorrhagic Fever with Renal Syndrome, Zoonoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpenGenome AI PlatformOther
AI-assisted biomedical signal extraction from free-text symptom descriptions, cross-referenced against PubMed and ClinicalTrials.gov evidence sources.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: OpenGenome AI Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal signal-source concordance rate
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
Measured: At point of automated report generation, assessed continuously over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start5 May 2026
- Primary completion5 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OpenGenome
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578610
- Sponsor's protocol ID
- OGNOME-OBS-2026-001
- Acronym
- OGNOME-REG
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Calibration of Evidence-Grounded Biomedical Signal Extraction From Free-Text Symptom Descriptions: A Prospective Observational Registry Using the OpenGenome Automated Research Instrument
- ClinicalTrials.gov ID
- NCT07578610
- Acronym / sponsor ID
- OGNOME-REG / OGNOME-OBS-2026-001
- Conditions
- Signs and Symptoms, Fever, Myalgia, Skin Diseases, Hemorrhagic Fever With Renal Syndrome, Zoonoses
- Keywords
- biomedical signal extraction, symptom analysis, PubMed
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- OpenGenomeResearch network
- Study start
- 5 May 2026 (actual)
- Primary completion
- 5 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voluntary Submitters | – | Other: OpenGenome AI PlatformAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpenGenome AI PlatformAI-assisted biomedical signal extraction from free-text symptom descriptions, cross-referenced against PubMed and ClinicalTrials.gov evidence sources. | Other | Voluntary Submitters |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Signs and Symptoms and Fever, run by OpenGenome at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Koch (+491634168231, richard@opengenome.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal signal-source concordance rate (time frame: At point of automated report generation, assessed continuously over 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.