A Study of Urine Volatile Organic Compounds for Disease Detection
NCT07933042, Not yet recruiting, Toby, Inc.
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of Urine Volatile Organic Compounds for Disease Detection | ClinicalTrials.gov |
| NCT number | NCT07933042 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 30,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Toby, Inc. | ClinicalTrials.gov |
| Conditions | Cancer, Alzheimer's Disease | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Clinical performance of each locked assay | At specimen collection and reference-standard assessment, including medical-record review at approximately 12 months where available. | Sensitivity and specificity at pre-specified thresholds, and area under the receiver operating characteristic curve, of each locked assay against the applicable reference standard in its intended-use population, using blinded validation specimens not used to develop that assay. Estimates will include 95% confidence intervals. | ClinicalTrials.gov |
| Primary | Paired comparison with available standard-of-care tests | At specimen collection and reference-standard assessment, including medical-record review at approximately 12 months where available. | Differences in sensitivity, specificity, and area under the receiver operating characteristic curve between each locked assay and each available standard-of-care test in the same participants, with 95% confidence intervals. | ClinicalTrials.gov |
| Secondary | Assay performance by subgroup and signal origin | At specimen collection and reference-standard assessment, including medical-record review at approximately 12 months where available. | Sensitivity, specificity, and area under the receiver operating characteristic curve across thresholds and by disease characteristics, populations, and control types, including stage, grade, and age; accuracy of signal-origin classification. | ClinicalTrials.gov |
| Secondary | Protocol-conforming specimens with final reference-standard classification | From specimen collection through reference-standard classification, including medical-record review at approximately 12 months where available. | Number of protocol-conforming urine specimens with final reference-standard classification, summarized by disease and control type. | ClinicalTrials.gov |
| Other | Candidate assays advanced to validation | From study start through study completion, estimated up to 5 years | Number of candidate assays developed using the Development Pool that are locked and carried forward to a Validation Plan. | ClinicalTrials.gov |
| Other | Exploratory prognostic and simulated clinical and economic outcomes | Up to 5 years after specimen collection, where follow-up is permitted and available | Where optional medical-record follow-up is available, compare progression, recurrence, treatment response, stage at diagnosis, procedures, health care use, and costs with blinded assay predictions. These are exploratory prognostic and simulated health-economic analyses; test results are not used in care. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)