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NCT03766958: ORACLE
A Registry to Evaluate the Performance of the BDX-XL2 Test
trial in Nodule Solitary Pulmonary in 842 participants. Completed in 23 May 2024.
12 May 2022
Quick facts
| Lead sponsor | Biodesix, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 842 |
| Start date | 16 October 2018 |
| Primary completion | 12 May 2022 |
| Estimated completion | 23 May 2024 |
| Sites | 15 locations across United States |
Conditions studied
- Nodule Solitary Pulmonary — all drugs for Nodule Solitary Pulmonary →
- NSCLC — all drugs for NSCLC →
Sponsor
Biodesix, Inc.
Who can join
40 and older, any sex, with Nodule Solitary Pulmonary or NSCLC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Assessing a biomarker's ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study.
Pritchett MA, Sigal B, Bowling MR, Kurman JS, et al · · 2023 · cited 8× · PMID 37432960 · DOI 10.1371/journal.pone.0287409 -
Using a Blood Biomarker to Distinguish Benign From Malignant Pulmonary Nodules: A Subgroup Analysis Comparing Screen Detection, Sex, Smoking History, and Nodule Size.
Long KJ, Pitcher T, Kurman JS, Pritchett MA, et al · · 2023 · cited 3× · PMID 37414335 · DOI 10.1016/j.chest.2023.06.037 -
Validation of a blood-based autoantibody test to assess lung cancer risk in 4-30 mm pulmonary nodules: a retrospective pooled analysis of four cohort studies.
Pitcher TJ, Long KJ, Kammer MN, Schuldheisz S, et al · · 2026 · PMID 41703731 · DOI 10.1080/14796694.2026.2626339
Verify or expand the search:
- PubMed search for NCT03766958
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Nodule Solitary Pulmonary
Currently open trials in the same condition.
- NCT03774758 — Biomarkers for Risk Stratification in Lung Cancer · recruiting
Other Biodesix, Inc. trials
Trials by the same sponsor.
- NCT06728319 — A Multicenter, Retrospective, Chart Review Study Evaluating the Impact and Utility of the Blood-Based Proteomic Integrat · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03766958 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biodesix, Inc.
- Last refreshed: 24 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03766958.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing