Evidence map›Paper›PMID 22898932›Full record

ArticleCancer2013

PAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma.

David V Gold, Jochen Gaedcke, B Michael Ghadimi, Michael Goggins, Ralph H Hruban, Mengling Liu, Guy Newsome, David M Goldenberg

Registry-linked trialAbstract readEvaluation Study
In one paragraph

Article in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01956812 (An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 12% 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.

NCT01956812 phase3terminatednot on this map

An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

TypeinterventionalSponsorGilead SciencesRan2013 to 2016Enrolled334ConditionsMetastatic Pancreatic Cancer, Pancreatic CancerArmsIMMU-107, placebo, Gemcitabine
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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  12. BioMed research international · 2020
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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

8 authors at 5 institutions in 2 countries.

David V GoldCenter for Molecular Medicine and Immunology, Garden State Cancer Center, Morris Plains, NJ 07950, USA. dvgold@gscancer.org
Jochen Gaedcke
B Michael Ghadimi
Michael Goggins
Ralph H Hruban
Mengling Liu
Guy Newsome
David M Goldenberg
Center for Molecular Medicine and Immunology · USUniversitätsmedizin Göttingen · DECancer Research Center · USJohns Hopkins University · USNew York University · US

Funding

Vaccine FacilityP30CA016087 · NCI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Drew R Jones · 1985 to 2026
$83.1M
Tumor Antigens for Individual Signatures and TherapyP50CA062924 · NCI · JOHNS HOPKINS UNIVERSITY · PI JAFFEE, ELIZABETH M. · 1993 to 2022
$54.6M
Detection and Diagnosis of Pancreatic CarcinomaR01CA096924 · NCI · CTR FOR MOLECULAR MEDICINE/IMMUNOLOGY · PI GOLD, DAVID V · 2005 to 2014
$2.3M
Detection and Diagnosis of Pancreatic CancerR56CA096924 · NCI · CTR FOR MOLECULAR MEDICINE/IMMUNOLOGY · PI GOLD, DAVID V · 2009 to 2009
$249k
NCI NIH HHS CA096924NCI NIH HHS P30 CA016087NCI NIH HHS P50 CA062924NCI NIH HHS R01 CA096924NCI NIH HHS R56 CA096924
6 · The paper itself

Abstract

backgroundThe monoclonal antibody PAM4 has high specificity for pancreatic ductal adenocarcinoma (PDAC), as well as its precursor lesions, but has not been found to be reactive with normal and benign pancreatic tissues. The objective of the current study was to evaluate a PAM4-based serum enzyme immunoassay alone and in combination with the carbohydrate antigen (CA) 19-9 assay for the detection of PDAC, with particular attention to early stage disease.

methodsSera from patients with confirmed PDAC (N = 298), other cancers (N = 99), benign disease of the pancreas (N = 120), and healthy adults (N = 79) were evaluated by a specific enzyme immunoassay for the concentration of PAM4 and CA 19-9 antigen levels by blinded analyses. All tests for statistical significance were 2-sided.

resultsThe overall sensitivity for PAM4 detection of PDAC was 76%, with 64% of patients with stage I disease also identified. The detection rate was considerably higher (85%) for patients with advanced disease. The assay demonstrated high specificity compared with benign pancreatic disease (85%), with a positive likelihood ratio of 4.93. CA 19-9 provided an overall sensitivity of 77%, and was positive in 58% of patients with stage I disease; however, the specificity was significantly lower for CA 19-9 (68%), with a positive likelihood ratio of 2.85 (P = .026 compared with PAM4). It is important to note that a combined PAM4 and CA 19-9 biomarker serum assay demonstrated an improved sensitivity (84%) for the overall detection of PDAC without a significant loss of specificity (82%) compared with either arm alone.

conclusionsThe PAM4 enzyme immunoassay identified approximately two-thirds of patients with stage I PDAC with high discriminatory power with respect to benign, nonneoplastic pancreatic disease. These results provide a rationale for testing patient groups considered to be at high risk for PDAC with a combined PAM4 and CA 19-9 biomarker serum assay for the detection of early stage PDAC.

Indexed as

AdenocarcinomaAdultAntigens, NeoplasmBlood Chemical AnalysisCA-19-9 AntigenCarcinoma, Pancreatic DuctalCase-Control StudiesEarly Detection of CancerFemaleHumansImmunoenzyme TechniquesMaleOsmolar ConcentrationPancreatic NeoplasmsSensitivity and SpecificityAntigens, NeoplasmCA-19-9 AntigenPAM4 protein, human

Identifiers

PMID22898932
PMCPMC3502643
OpenAlexW1605476605

What OpenQuestion holds

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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.