An observational study in Cancer and Alzheimer's Disease, sponsored by Toby, Inc.. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Toby, Inc. · Observational
The goal of this observational study is to develop and evaluate urine tests for detecting disease in adults. It will initially focus on prostate, bladder, and kidney cancer. Researchers will compare urine samples and medical records from people with and without these diseases to see whether the tests can detect them accurately. Participants may provide a urine sample during a routine visit. Study results will not be returned to participants or used in their care.
TOBY ATLAS is a multi-center master protocol that supports the development and validation of urine-based tests for screening, diagnosis, and monitoring of multiple diseases. The study uses prospectively collected, residual, banked, and purchased urine samples, where permitted.
Researchers will analyze urine for volatile organic compounds using gas chromatography-mass spectrometry and develop models using samples with known disease status. Each model will be locked before it is evaluated using a separate set of blinded samples.
Disease status and available standard-of-care test results will be obtained from medical records. Researchers may also review records over time to identify later diagnoses or outcomes. Sites and diseases may be added as the study progresses.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Toby, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adults with target diseases and comparison participants, including healthy volunteers and individuals with other diseases, benign conditions, or negative diagnostic work-ups. Participants are identified through routine care and other permitted specimen sources.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with a target disease established by the applicable reference standard, including participants assessed after treatment where specified.
Participants without the target disease for a given analysis, including healthy participants and participants with other diseases, benign conditions, or negative diagnostic work-ups.
Clinical performance of each locked assay
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.
Time frame: At specimen collection and reference-standard assessment, including medical-record review at approximately 12 months where available.
Paired comparison with available standard-of-care tests
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.
Time frame: At specimen collection and reference-standard assessment, including medical-record review at approximately 12 months where available.
Assay performance by subgroup and signal origin
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.
Time frame: At specimen collection and reference-standard assessment, including medical-record review at approximately 12 months where available.
Protocol-conforming specimens with final reference-standard classification
Number of protocol-conforming urine specimens with final reference-standard classification, summarized by disease and control type.
Time frame: From specimen collection through reference-standard classification, including medical-record review at approximately 12 months where available.
Candidate assays advanced to validation
Number of candidate assays developed using the Development Pool that are locked and carried forward to a Validation Plan.
Time frame: From study start through study completion, estimated up to 5 years
Exploratory prognostic and simulated clinical and economic outcomes
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.
Time frame: Up to 5 years after specimen collection, where follow-up is permitted and available
No study locations are listed for this record.
Plan to share: No — There is currently no plan to make individual participant data available to other researchers.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2032, 60 months later.
Of 148 industry-sponsored observational studies under Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 102. This study's planned 60 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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