Evidence map›Paper›PMID 31419640›Full record

ArticleThe Journal of surgical research2020

Development of Malignancy-Risk Gene Signature Assay for Predicting Breast Cancer Risk.

James Sun, Dung-Tsa Chen, Jiannong Li, Weihong Sun, Sean J Yoder, Tania E Mesa, Marek Wloch, Richard Roetzheim, Christine Laronga, M Catherine Lee

Open access · greenAbstract readValidation Study
In one paragraph

Article in The Journal of surgical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 58% of its field
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Article
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 at 1 institution in 1 country.

James SunDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida.
Dung-Tsa ChenDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.
Jiannong LiDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.
Weihong SunDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida.
Sean J YoderMolecular Genomics Core Facility, Moffitt Cancer Center, Tampa, Florida.
Tania E MesaMolecular Genomics Core Facility, Moffitt Cancer Center, Tampa, Florida.
Marek WlochTissue Core, Moffitt Cancer Center, Tampa, Florida.
Richard RoetzheimDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida.
Christine LarongaDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida.
M Catherine LeeDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, Florida. Electronic address: Marie.Lee@moffitt.org.
Moffitt Cancer Center · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
Research Pilot ProjectP20CA202920 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI GWEDE, CLEMENT K. · 2017 to 2020
$1.2M
Development of the Malignancy-Risk Gene Signature Assay for Predicting Breast Cancer RiskR21CA198762 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI LEE, MARIE CATHERINE · 2015 to 2016
$407k
NCI NIH HHS P20 CA202920NCI NIH HHS P30 CA076292NCI NIH HHS R21 CA198762
6 · The paper itself

Abstract

backgroundBreast cancer (BC) risk assessment models are statistical estimates based on patient characteristics. We developed a gene expression assay to assess BC risk using benign breast biopsy tissue.

methodsA NanoString-based malignancy risk (MR) gene signature was validated for formalin-fixed paraffin-embedded (FFPE) tissue. It was applied to FFPE benign and BC specimens obtained from women who underwent breast biopsy, some of whom developed BC during follow-up to evaluate diagnostic capability of the MR signature. BC risk was calculated with MR score, Gail risk score, and both tests combined. Logistic regression and receiver operating characteristic curves were used to evaluate these 3 models.

resultsNanoString MR demonstrated concordance between fresh frozen and FFPE malignant samples (r = 0.99). Within the validation set, 563 women with benign breast biopsies from 2007 to 2011 were identified and followed for at least 5 y; 50 women developed BC (affected) within 5 y from biopsy. Three groups were compared: benign tissue from unaffected and affected patients and malignant tissue from affected patients. Kruskal-Wallis test suggested difference between the groups (P = 0.09) with trend in higher predicted MR score for benign tissue from affected patients before development of BC. Neither the MR signature nor Gail risk score were statistically different between affected and unaffected patients; combining both tests demonstrated best predictive value (AUC = 0.71).

conclusionsFFPE gene expression assays can be used to develop a predictive test for BC. Further investigation of the combined MR signature and Gail Model is required. Our assay was limited by scant cellularity of archived breast tissue.

Indexed as

AdultAgedBiomarkers, TumorBiopsyBreastBreast NeoplasmsFemaleFollow-Up StudiesGene Expression ProfilingHumansMiddle AgedPredictive Value of TestsRisk AssessmentROC CurveTissue Array AnalysisTranscriptomeBiomarkers, TumorBreast cancerCancer riskGail ModelGene expressionGene signatureNanoString

Identifiers

PMID31419640
PMCPMC6900446
OpenAlexW2967725770

What OpenQuestion holds

Textmetadata
LicenceTDM
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.