Evidence map›Paper›PMID 40296864›Full record

ArticleCHEST pulmonary2025

Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules.

Kathryn J Long, Gerard A Silvestri, Michael N Kammer, Sarah Gibbs, Wei Wu, Monica Johal, Sudhakar Pipavath, Trevor Pitcher, James Jett, Viswam S Nair

Registry-linked trialAbstract read
In one paragraph

Article in CHEST pulmonary, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01752114 (Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01752114 completednot on this map

Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

TypeobservationalSponsorIntegrated DiagnosticsRan2012 to 2016Enrolled684ConditionsPrecancerous Conditions, Carcinoma
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Kathryn J LongMedical University of South Carolina, Charleston, SC.
Gerard A SilvestriMedical University of South Carolina, Charleston, SC.
Michael N KammerVanderbilt University Medical Center, Nashville, TN.
Sarah GibbsClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.
Wei WuDepartment of Radiology, University of Washington School of Medicine, Seattle, WA.
Monica JohalClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.
Sudhakar PipavathDepartment of Radiology, University of Washington School of Medicine, Seattle, WA.
Trevor PitcherBiodesix Inc, Boulder, CO.
James JettBiodesix Inc, Boulder, CO.
Viswam S NairClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Eric Collisson · 1985 to 2026
$296.4M
Pulmonary Focused Foundations in Innovation and Scholarship (PuFFInS)T32HL144470 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Carol A. Feghali-Bostwick · 2019 to 2026
$2.6M
Scleroderma Twin Study and analysis of Estrogen in patients with dcSScK24AR060297 · NIAMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI FEGHALI-BOSTWICK, CAROL A. · 2013 to 2025
$1.4M
NCI NIH HHS P30 CA015704NHLBI NIH HHS T32 HL144470NIAMS NIH HHS K24 AR060297
6 · The paper itself

Abstract

backgroundPulmonary nodules (PNs) are frequently detected by chest CT scan, which is increasingly used in clinical practice. Accurately identifying malignant nodules can pose a diagnostic challenge; therefore, a high-specificity biomarker could help clinicians identify malignant nodules and ideally lead to the earlier diagnosis of lung cancer. RESEARCH QUESTION: What are the performance characteristics of a blood-based biomarker for identifying malignancy in patients with a CT-detected PN? STUDY DESIGN AND

methodsBanked plasma samples from 2 independent prospective observational cohorts of patients presenting with benign or malignant PNs 8 to 30 mm in size were tested using a 7-autoantibody panel. Sensitivity, specificity, and positive predictive value of the autoantibody test (AAT) to identify cancer were calculated for the individual and combined cohorts.

resultsOverall, 447 patients (263 and 184 from each cohort) were included in the analysis with a prevalence of malignancy of 55%. The performance of the AAT between the 2 cohorts was similar. The AAT demonstrated a specificity of 90% (95% CI, 85%-93%), a positive predictive value of 66% (95% CI, 52%-77%), sensitivity of 16% (95% CI, 12%-22%), and false-positive rate of 10% in the combined cohort. Using a pretest probability of cancer cutoff of 20% improved the positive predictive value to 76% (95% CI, 61%-88%) and resulted in a 52% decrease in the number of false-positive test results. In the subset of patients who had 18F-fluorodeoxyglucose PET imaging performed for clinical purposes (n = 222), specificity of the AAT was higher (93% vs 58%,

interpretationThis study validates the specificity of a blood-based autoantibody biomarker for identifying malignancy in patients with indeterminate PNs. This rule-in biomarker may help to expedite workup of malignant nodules. CLINICAL

trial registrationClinicalTrials.gov; No.: NCT01752114; URL: www.clinicaltrials.gov CHEST Pulmonary 2025; 3(1):100130.

Indexed as

autoantibodyblood-based biomarkerlung cancerpulmonary nodulerisk reclassification

Identifiers

PMID40296864
PMCPMC12037156

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.