Evidence map›Paper›PMID 28960111›Full record

GuidelineAmerican journal of respiratory and critical care medicine2017

Evaluating Molecular Biomarkers for the Early Detection of Lung Cancer: When Is a Biomarker Ready for Clinical Use? An Official American Thoracic Society Policy Statement.

Peter J Mazzone, Catherine Rufatto Sears, Doug A Arenberg, Mina Gaga, Michael K Gould, Pierre P Massion, Vish S Nair, Charles A Powell, Gerard A Silvestri, Anil Vachani and 2 more

Abstract readPractice Guideline
In one paragraph

Guideline in American journal of respiratory and critical care medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 4 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Classification of Salivary Gland Tumors on Ultrasound Using Artificial Intelligence: A Systematic Review and Meta-Analysis.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
    Pooled it
  2. Knowledge translation strategies to enhance lung cancer screening programme implementation: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2025
    Pooled it
  3. Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives.European journal of nuclear medicine and molecular imaging · 2021
    Pooled it
  4. Pooled it
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  8. Leveraging Commercially Available Protein Assays as Biomarkers for Lung Cancer.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2026
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18 more citing papers are in PubMed but not listed here.

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

12 authors.

Peter J Mazzone
Catherine Rufatto Sears
Doug A Arenberg
Mina Gaga
Michael K Gould
Pierre P Massion
Vish S Nair
Charles A Powell
Gerard A Silvestri
Anil Vachani
Renda Soylemez Wiener
ATS Assembly on Thoracic Oncology

Funding

Translational Research Support CoreP30ES013508 · NIEHS · UNIVERSITY OF PENNSYLVANIA · PI Rebecca A Simmons · 2006 to 2026
$35.3M
Validation of Biomarkers of Risk for the Early Detection of Lung CancerU01CA152662 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DEPPEN, STEPHEN, GROGAN, ERIC L · 2010 to 2025
$12.8M
Lung Adenocarcinoma Invasion GenomicsR01CA163772 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI MASSION, PIERRE P., POWELL, CHARLES A. · 2013 to 2017
$2.9M
NCI NIH HHS R01 CA163772NCI NIH HHS U01 CA152662NIEHS NIH HHS P30 ES013508
6 · The paper itself

Abstract

backgroundMolecular biomarkers have the potential to improve the current state of early lung cancer detection. The goal of this project was to develop a policy statement that provides guidance about the level of evidence required to determine that a molecular biomarker, used to support early lung cancer detection, is appropriate for clinical use.

methodsAn ad hoc project steering committee was formed, to include individuals with expertise in the early detection of lung cancer and molecular biomarker development, from inside and outside of the Assembly on Thoracic Oncology. Key questions, generated from the results of a survey of the project steering committee, were discussed at an in-person meeting. Results of the discussion were summarized in a policy statement that was circulated to the steering committee and revised multiple times to achieve consensus.

resultsWith a focus on the clinical applications of lung cancer screening and lung nodule evaluation, the policy statement outlines categories of results that should be reported in the early phases of molecular biomarker development, discusses the level of evidence that would support study of the clinical utility, describes the outcomes that should be proven to consider a molecular biomarker clinically useful, and suggests study designs capable of assessing these outcomes.

conclusionsThe application of molecular biomarkers to assist with the early detection of lung cancer has the potential to substantially improve our ability to select patients for lung cancer screening, and to assist with the characterization of indeterminate lung nodules. We have described relevant considerations and have suggested standards to apply when determining whether a molecular biomarker for the early detection of lung cancer is ready for clinical use.

Indexed as

Biomarkers, TumorEarly Detection of CancerHumansLung NeoplasmsSocieties, MedicalUnited StatesBiomarkers, Tumorclinical utilitylung cancer screeninglung nodulesoutcomesstudy design

Identifiers

PMID28960111
PMCPMC5803661

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.