Longitudinal StudiesProspective StudiesBiomarkersPredictive Value of TestsTelemedicineTime of DeathTime PerceptionTime ReactionTime EfficiencyTime ManagementPopulationPopulation GroupsEpidemic DiseasePandemicSex BehaviorSex CharacteristicsSex HormoneCardio-pulmonarySurgicalDrugs of AbuseHealth RisksClinical Outcomes
Investigational drug(s) / intervention(s)
No Study-Assigned Intervention
No Study-Assigned Intervention: This is a prospective observational study with no protocol-assigned drug, biologic, device, behavioral intervention, or other therapeutic intervention. Participants receive clinical care according to usual practice and applicable clinical decisions. The study observes and analyzes longitudinal clinical and physiologic data to characterize temporal dynamics and their association with clinically meaningful outcomes. Data collection may include routinely available clinical measurements, laboratory results, imaging-derived measurements, patient-reported information, and remote or digital health measurements when permitted by the protocol.
Study summary
TH-CLINICAL-TIME is a prospective, longitudinal observational study evaluating how changes in clinical measurements over time may help researchers better understand patient health trajectories and clinically meaningful outcomes. The study will examine patterns such as changes from an individual's baseline, rate of change, persistence of abnormalities, variability, recurrence, and recovery following clinical events. Data may include routinely collected clinical measurements, physiologic observations, laboratory results, cardiac measurements, imaging-derived measurements, patient-reported information, and remote or digital health data when available and permitted by the study protocol. The study will investigate whether these temporal patterns provide additional information beyond individual measurements taken at a single point in time. The planned study horizon extends from 2026 through 2076, while individual participant follow-up will occur according to the approved study schedule, consent, and applicable requirements.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Adults aged 18 years or older.
* Able and willing to provide informed consent, when informed consent is required by the approved study protocol and applicable regulations.
* Willing and able to participate in longitudinal collection or evaluation of clinical, physiologic, laboratory, imaging-derived, patient-reported, or remote/digital health information as applicable to the study protocol.
* Ability to complete the protocol-defined follow-up schedule or provide sufficient longitudinal observations for analysis.
* Individuals with or without established medical conditions may be eligible, provided their participation is consistent with the study protocol.
* Availability of sufficient baseline information or measurements to establish an individualized reference state when required for the applicable analysis.
Exclusion Criteria:
* Inability to provide informed consent when consent is required and no legally authorized representative process is applicable.
* Inability to comply with protocol-defined data collection or follow-up requirements.
* Circumstances that, in the judgment of the investigator, would prevent reliable longitudinal data collection or interpretation.
* Enrollment in another research protocol that would materially interfere with participation or interpretation of the outcomes, when applicable.
* Any other exclusion criterion specifically identified in the IRB/ethics-approved protocol.
Primary outcome measure(s)
Time-Dependent Predictive Discrimination of Clinically Meaningful Patient Outcomes — At baseline and at 30 days, 90 days, 6 months, and 12 months after enrollment. Change in predictive discrimination of longitudinal temporal clinical features compared with point-in-time clinical measurements for prespecified clinically meaningful patient outcomes. Predictive discrimination will be quantified using the prespecified time-dependent area under the receiver operating characteristic curve (AUC) or concordance index (C-index), as applicable to the outcome and statistical analysis plan. Temporal features will include individualized baseline values and longitudinal rates of change.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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