A rigorous multi-laboratory study of known PDAC biomarkers identifies increased sensitivity and specificity over CA19-9 alone

A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC biomarkers that could improve biomarker performance over CA19-9 alone, but the performance of the previously reported biomarkers in combinatio...

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Veröffentlicht in:	Cancer letters Jg. 604; S. 217245
Hauptverfasser:	Haab, Brian, Qian, Lu, Staal, Ben, Jain, Maneesh, Fahrmann, Johannes, Worthington, Christine, Prosser, Denise, Velokokhatnaya, Liudmila, Lopez, Camden, Tang, Runlong, Hurd, Mark W., Natarajan, Gopalakrishnan, Kumar, Sushil, Smith, Lynette, Hanash, Sam, Batra, Surinder K., Maitra, Anirban, Lokshin, Anna, Huang, Ying, Brand, Randall E.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Ireland Elsevier B.V 01.11.2024
Schlagworte:	Aged Antigens, Tumor-Associated, Carbohydrate - blood Biomarkers Biomarkers, Tumor - blood CA 19–9 CA-19-9 Antigen - blood Carcinoma, Pancreatic Ductal - blood Carcinoma, Pancreatic Ductal - diagnosis Carcinoma, Pancreatic Ductal - pathology Case-Control Studies Early detection Female Humans Male Middle Aged Pancreatic adenocarcinoma Pancreatic Neoplasms - blood Pancreatic Neoplasms - diagnosis Pancreatic Neoplasms - pathology Panel Sensitivity and Specificity Pancreatic adenocarcinoma Biomarkers Panel CA 19–9 Early detection
ISSN:	0304-3835, 1872-7980, 1872-7980
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Abstract	A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC biomarkers that could improve biomarker performance over CA19-9 alone, but the performance of the previously reported biomarkers in combination is not known. Therefore, we conducted a coordinated case/control study across multiple laboratories using common sets of blinded training and validation samples (132 and 295 plasma samples, respectively) from PDAC patients and non-PDAC control subjects representing conditions under which surveillance occurs. We analyzed the training set to identify candidate biomarker combination panels using biomarkers across laboratories, and we applied the fixed panels to the validation set. The panels identified in the training set, CA19-9 with CA199.STRA, LRG1, TIMP-1, TGM2, THSP2, ANG, and MUC16.STRA, achieved consistent performance in the validation set. The panel of CA19-9 with the glycan biomarker CA199.STRA improved sensitivity from 0.44 with 0.98 specificity for CA19-9 alone to 0.71 with 0.98 specificity (p < 0.001, 1000-fold bootstrap). Similarly, CA19-9 combined with the protein biomarker LRG1 and CA199.STRA improved specificity from 0.16 with 0.94 sensitivity for CA19-9 to 0.65 with 0.89 sensitivity (p < 0.001, 1000-fold bootstrap). We further validated significantly improved performance using biomarker panels that did not include CA19-9. This study establishes the effectiveness of a coordinated study of previously discovered biomarkers and identified panels of those biomarkers that significantly increased the sensitivity and specificity of early-stage PDAC detection in a rigorous validation trial. •A coordinated study of previously discovered biomarkers reveals combined value.•New combinations of known biomarkers significantly increased biomarker performance.•Previously known biomarkers detect complementary subsets of patients without CA19-9.
AbstractList	A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC biomarkers that could improve biomarker performance over CA19-9 alone, but the performance of the previously reported biomarkers in combination is not known. Therefore, we conducted a coordinated case/control study across multiple laboratories using common sets of blinded training and validation samples (132 and 295 plasma samples, respectively) from PDAC patients and non-PDAC control subjects representing conditions under which surveillance occurs. We analyzed the training set to identify candidate biomarker combination panels using biomarkers across laboratories, and we applied the fixed panels to the validation set. The panels identified in the training set, CA19-9 with CA199.STRA, LRG1, TIMP-1, TGM2, THSP2, ANG, and MUC16.STRA, achieved consistent performance in the validation set. The panel of CA19-9 with the glycan biomarker CA199.STRA improved sensitivity from 0.44 with 0.98 specificity for CA19-9 alone to 0.71 with 0.98 specificity (p < 0.001, 1000-fold bootstrap). Similarly, CA19-9 combined with the protein biomarker LRG1 and CA199.STRA improved specificity from 0.16 with 0.94 sensitivity for CA19-9 to 0.65 with 0.89 sensitivity (p < 0.001, 1000-fold bootstrap). We further validated significantly improved performance using biomarker panels that did not include CA19-9. This study establishes the effectiveness of a coordinated study of previously discovered biomarkers and identified panels of those biomarkers that significantly increased the sensitivity and specificity of early-stage PDAC detection in a rigorous validation trial. A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC biomarkers that could improve biomarker performance over CA19-9 alone, but the performance of the previously reported biomarkers in combination is not known. Therefore, we conducted a coordinated case/control study across multiple laboratories using common sets of blinded training and validation samples (132 and 295 plasma samples, respectively) from PDAC patients and non-PDAC control subjects representing conditions under which surveillance occurs. We analyzed the training set to identify candidate biomarker combination panels using biomarkers across laboratories, and we applied the fixed panels to the validation set. The panels identified in the training set, CA19-9 with CA199.STRA, LRG1, TIMP-1, TGM2, THSP2, ANG, and MUC16.STRA, achieved consistent performance in the validation set. The panel of CA19-9 with the glycan biomarker CA199.STRA improved sensitivity from 0.44 with 0.98 specificity for CA19-9 alone to 0.71 with 0.98 specificity (p < 0.001, 1000-fold bootstrap). Similarly, CA19-9 combined with the protein biomarker LRG1 and CA199.STRA improved specificity from 0.16 with 0.94 sensitivity for CA19-9 to 0.65 with 0.89 sensitivity (p < 0.001, 1000-fold bootstrap). We further validated significantly improved performance using biomarker panels that did not include CA19-9. This study establishes the effectiveness of a coordinated study of previously discovered biomarkers and identified panels of those biomarkers that significantly increased the sensitivity and specificity of early-stage PDAC detection in a rigorous validation trial. A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC biomarkers that could improve biomarker performance over CA19-9 alone, but the performance of the previously reported biomarkers in combination is not known. Therefore, we conducted a coordinated case/control study across multiple laboratories using common sets of blinded training and validation samples (132 and 295 plasma samples, respectively) from PDAC patients and non-PDAC control subjects representing conditions under which surveillance occurs. We analyzed the training set to identify candidate biomarker combination panels using biomarkers across laboratories, and we applied the fixed panels to the validation set. The panels identified in the training set, CA19-9 with CA199.STRA, LRG1, TIMP-1, TGM2, THSP2, ANG, and MUC16.STRA, achieved consistent performance in the validation set. The panel of CA19-9 with the glycan biomarker CA199.STRA improved sensitivity from 0.44 with 0.98 specificity for CA19-9 alone to 0.71 with 0.98 specificity (p < 0.001, 1000-fold bootstrap). Similarly, CA19-9 combined with the protein biomarker LRG1 and CA199.STRA improved specificity from 0.16 with 0.94 sensitivity for CA19-9 to 0.65 with 0.89 sensitivity (p < 0.001, 1000-fold bootstrap). We further validated significantly improved performance using biomarker panels that did not include CA19-9. This study establishes the effectiveness of a coordinated study of previously discovered biomarkers and identified panels of those biomarkers that significantly increased the sensitivity and specificity of early-stage PDAC detection in a rigorous validation trial. •A coordinated study of previously discovered biomarkers reveals combined value.•New combinations of known biomarkers significantly increased biomarker performance.•Previously known biomarkers detect complementary subsets of patients without CA19-9. A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC biomarkers that could improve biomarker performance over CA19-9 alone, but the performance of the previously reported biomarkers in combination is not known. Therefore, we conducted a coordinated case/control study across multiple laboratories using common sets of blinded training and validation samples (132 and 295 plasma samples, respectively) from PDAC patients and non-PDAC control subjects representing conditions under which surveillance occurs. We analyzed the training set to identify candidate biomarker combination panels using biomarkers across laboratories, and we applied the fixed panels to the validation set. The panels identified in the training set, CA19-9 with CA199.STRA, LRG1, TIMP-1, TGM2, THSP2, ANG, and MUC16.STRA, achieved consistent performance in the validation set. The panel of CA19-9 with the glycan biomarker CA199.STRA improved sensitivity from 0.44 with 0.98 specificity for CA19-9 alone to 0.71 with 0.98 specificity (p < 0.001, 1000-fold bootstrap). Similarly, CA19-9 combined with the protein biomarker LRG1 and CA199.STRA improved specificity from 0.16 with 0.94 sensitivity for CA19-9 to 0.65 with 0.89 sensitivity (p < 0.001, 1000-fold bootstrap). We further validated significantly improved performance using biomarker panels that did not include CA19-9. This study establishes the effectiveness of a coordinated study of previously discovered biomarkers and identified panels of those biomarkers that significantly increased the sensitivity and specificity of early-stage PDAC detection in a rigorous validation trial.A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC biomarkers that could improve biomarker performance over CA19-9 alone, but the performance of the previously reported biomarkers in combination is not known. Therefore, we conducted a coordinated case/control study across multiple laboratories using common sets of blinded training and validation samples (132 and 295 plasma samples, respectively) from PDAC patients and non-PDAC control subjects representing conditions under which surveillance occurs. We analyzed the training set to identify candidate biomarker combination panels using biomarkers across laboratories, and we applied the fixed panels to the validation set. The panels identified in the training set, CA19-9 with CA199.STRA, LRG1, TIMP-1, TGM2, THSP2, ANG, and MUC16.STRA, achieved consistent performance in the validation set. The panel of CA19-9 with the glycan biomarker CA199.STRA improved sensitivity from 0.44 with 0.98 specificity for CA19-9 alone to 0.71 with 0.98 specificity (p < 0.001, 1000-fold bootstrap). Similarly, CA19-9 combined with the protein biomarker LRG1 and CA199.STRA improved specificity from 0.16 with 0.94 sensitivity for CA19-9 to 0.65 with 0.89 sensitivity (p < 0.001, 1000-fold bootstrap). We further validated significantly improved performance using biomarker panels that did not include CA19-9. This study establishes the effectiveness of a coordinated study of previously discovered biomarkers and identified panels of those biomarkers that significantly increased the sensitivity and specificity of early-stage PDAC detection in a rigorous validation trial.
ArticleNumber	217245
Author	Worthington, Christine Tang, Runlong Brand, Randall E. Batra, Surinder K. Kumar, Sushil Jain, Maneesh Natarajan, Gopalakrishnan Smith, Lynette Hanash, Sam Staal, Ben Hurd, Mark W. Haab, Brian Qian, Lu Prosser, Denise Velokokhatnaya, Liudmila Maitra, Anirban Fahrmann, Johannes Lokshin, Anna Huang, Ying Lopez, Camden
AuthorAffiliation	2 Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 19024 5 MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030 1 Van Andel Institute, 333 Bostwick NE, Grand Rapids, MI 49503 3 University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA 15213-2582 4 University of Nebraska Medical Center, 42nd and Emile Streets, Omaha, NE 68198
AuthorAffiliation_xml	– name: 2 Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 19024 – name: 5 MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030 – name: 3 University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA 15213-2582 – name: 4 University of Nebraska Medical Center, 42nd and Emile Streets, Omaha, NE 68198 – name: 1 Van Andel Institute, 333 Bostwick NE, Grand Rapids, MI 49503
Author_xml	– sequence: 1 givenname: Brian orcidid: 0000-0002-3471-1535 surname: Haab fullname: Haab, Brian email: brian.haab@vai.org organization: Van Andel Institute, 333 Bostwick NE, Grand Rapids, MI, 49503, USA – sequence: 2 givenname: Lu surname: Qian fullname: Qian, Lu organization: Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA, 19024, USA – sequence: 3 givenname: Ben orcidid: 0009-0001-0008-4588 surname: Staal fullname: Staal, Ben organization: Van Andel Institute, 333 Bostwick NE, Grand Rapids, MI, 49503, USA – sequence: 4 givenname: Maneesh surname: Jain fullname: Jain, Maneesh organization: University of Nebraska Medical Center, 42nd and Emile Streets, Omaha, NE, 68198, USA – sequence: 5 givenname: Johannes surname: Fahrmann fullname: Fahrmann, Johannes organization: MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA – sequence: 6 givenname: Christine surname: Worthington fullname: Worthington, Christine organization: University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA, 15213-2582, USA – sequence: 7 givenname: Denise surname: Prosser fullname: Prosser, Denise organization: University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA, 15213-2582, USA – sequence: 8 givenname: Liudmila surname: Velokokhatnaya fullname: Velokokhatnaya, Liudmila organization: University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA, 15213-2582, USA – sequence: 9 givenname: Camden orcidid: 0000-0003-4516-8088 surname: Lopez fullname: Lopez, Camden organization: Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA, 19024, USA – sequence: 10 givenname: Runlong surname: Tang fullname: Tang, Runlong organization: Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA, 19024, USA – sequence: 11 givenname: Mark W. surname: Hurd fullname: Hurd, Mark W. organization: MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA – sequence: 12 givenname: Gopalakrishnan surname: Natarajan fullname: Natarajan, Gopalakrishnan organization: University of Nebraska Medical Center, 42nd and Emile Streets, Omaha, NE, 68198, USA – sequence: 13 givenname: Sushil orcidid: 0000-0002-2155-3443 surname: Kumar fullname: Kumar, Sushil organization: University of Nebraska Medical Center, 42nd and Emile Streets, Omaha, NE, 68198, USA – sequence: 14 givenname: Lynette surname: Smith fullname: Smith, Lynette organization: University of Nebraska Medical Center, 42nd and Emile Streets, Omaha, NE, 68198, USA – sequence: 15 givenname: Sam surname: Hanash fullname: Hanash, Sam organization: MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA – sequence: 16 givenname: Surinder K. orcidid: 0000-0001-9470-9317 surname: Batra fullname: Batra, Surinder K. organization: University of Nebraska Medical Center, 42nd and Emile Streets, Omaha, NE, 68198, USA – sequence: 17 givenname: Anirban surname: Maitra fullname: Maitra, Anirban organization: MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA – sequence: 18 givenname: Anna surname: Lokshin fullname: Lokshin, Anna organization: University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA, 15213-2582, USA – sequence: 19 givenname: Ying orcidid: 0000-0002-9655-7502 surname: Huang fullname: Huang, Ying organization: Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA, 19024, USA – sequence: 20 givenname: Randall E. surname: Brand fullname: Brand, Randall E. email: brandre@upmc.edu organization: University of Pittsburgh Medical Center, 200 Lothrop St., Pittsburgh, PA, 15213-2582, USA
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Keywords	Pancreatic adenocarcinoma Biomarkers Panel CA 19–9 Early detection
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Snippet	A blood test that enables surveillance for early-stage pancreatic ductal adenocarcinoma (PDAC) is an urgent need. Independent laboratories have reported PDAC...
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SubjectTerms	Aged Antigens, Tumor-Associated, Carbohydrate - blood Biomarkers Biomarkers, Tumor - blood CA 19–9 CA-19-9 Antigen - blood Carcinoma, Pancreatic Ductal - blood Carcinoma, Pancreatic Ductal - diagnosis Carcinoma, Pancreatic Ductal - pathology Case-Control Studies Early detection Female Humans Male Middle Aged Pancreatic adenocarcinoma Pancreatic Neoplasms - blood Pancreatic Neoplasms - diagnosis Pancreatic Neoplasms - pathology Panel Sensitivity and Specificity
Title	A rigorous multi-laboratory study of known PDAC biomarkers identifies increased sensitivity and specificity over CA19-9 alone
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