An observational study in Nodule Solitary Pulmonary and NSCLC, sponsored by Biodesix, Inc.. Completed at 15 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Biodesix, Inc. · Observational
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Among 27 studies in Solitary Pulmonary Nodule with a site in United States — 4 open to participants now, 8 under way, none of them phase 3. Solitary Pulmonary Nodule · United States.
Among the 27 studies in Solitary Pulmonary Nodule with a site in United States, this one is the 4th largest by enrollment of the 15 observational ones that give a count, is the only one that started in 2018, is one of 15 observational ones, and was the 13th registered.
93 studies on the registry are indexed under Solitary Pulmonary Nodule; 20 are open to participants now.
Browse Solitary Pulmonary Nodule studies →4 of the 27 studies in Solitary Pulmonary Nodule with a site in United States are open now. Recruiting first, the newest first:
Abramson Cancer Center at Penn Medicine · Sites in United States
Ages 35–89
Veracyte, Inc. · Sites in United States, Puerto Rico
Ages 29–85
University of California, San Francisco · Sites in United States
Ages 40+
University of Florida · Sites in United States
Ages 50–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 12 Solitary Pulmonary Nodule studies recruiting now, 6 (50%) set no upper age limit and 1 (8%) stops at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2
First in 2005; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 842 is above the median of 401 across 45 observational studies indexed under Solitary Pulmonary Nodule.
Median enrollment 37 across the 12 interventional studies, 187 across the 15 observational. Of the 18 that completed or were terminated, 4 (22%) have results posted.
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11 of 27 have an industry lead sponsor. The 10 most frequent:
Biodesix, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Biodesix, Inc. has 2 studies filed under Solitary Pulmonary Nodule — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Solitary Pulmonary Nodule with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of the ORACLE Registry is to demonstrate clinical utility of the BDX-XL2 test; specifically, the potential to reduce unnecessary invasive procedures, such as biopsies and surgeries, on benign lung nodules while not significantly increasing the number of malignant lung nodules routed to CT surveillance. Clinical data will be collected from participating patients to evaluate the impact of the BDX-XL2 test when used in the clinical management of recently identified lung nodules assessed to have a low to moderate risk of cancer.
Patients will be identified from the patient populations of participating pulmonary medicine practices.
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.
Patient meets the criteria for the intended use population of Nodify Lung testing:
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients providing consent to have data collected to observe how Nodify Lung results were used in the clinical management of their lung nodules.
Contemporaneous group who did not have Nodify Lung test results for use in the clinical management of their lung nodules.
Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
Time frame: Up to 2 years
Ran from Oct 2018 to primary completion in May 2022, 42 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Biodesix, Inc.