Blood Markers of Early Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03568630

Recruitment Status : Recruiting

First Posted : June 25, 2018

Last Update Posted : November 19, 2018

See Contacts and Locations

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Kelsey Klute, University of Nebraska

Study Description

Brief Summary:

Identifying biomarkers of early pancreatic ductal adenocarcinoma (PDAC) could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease.

The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens.

Condition or disease	Intervention/treatment
Diabetes Mellitus, Type 2 PreDiabetes Pancreas Cyst Chronic Pancreatitis Genetic Predisposition to Disease Inherited Disease	Diagnostic Test: Mixed Meal Tolerance Test Diagnostic Test: Hemoglobin A1c Diagnostic Test: Other exploratory blood biomarkers

Detailed Description:

Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) have only an 8% chance of surviving 5 years after diagnosis. Most PDAC is advanced and not amenable to curative therapies at the time of diagnosis, owing to lack of symptoms in early disease, nonspecific symptoms when they do develop resulting in a delay in diagnosis. Identifying biomarkers of early PDAC could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease.

The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens. Subjects will include individuals with family history of pancreas cancer, individuals with cystic pancreas lesions or chronic pancreatitis, and individuals with new-onset diabetes. Identifying specific biomarkers - blood markers and/or a clinical "prodrome" - in participants who go on to develop PDAC could improve the diagnostic approach outcomes for patients diagnosed with PDAC.

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	1250 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer
Actual Study Start Date :	July 26, 2018
Estimated Primary Completion Date :	July 2023
Estimated Study Completion Date :	July 2023

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Hereditary pancreatitis

MedlinePlus related topics: Pancreatic Cancer

Drug Information available for: Pancreatin Pancrelipase Creon

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
New Onset Diabetes/High-Risk Prediabetes Must meet one of the following criteria: New onset type 2 diabetes diagnosed within the past 3 years, defined as Hemoglobin A1c ≥ 6.5%*, fasting blood glucose >126mg/dL confirmed on a subsequent day or as diagnosed by a physician High-risk pre-diabetes: Hemoglobin A1c >6.3% or A1c >6.0% with fasting blood glucose >110 or 2 hour oral glucose tolerance test between 140-200mg/dL; subjects who have been on metformin <3 years are eligible	Diagnostic Test: Mixed Meal Tolerance Test The goal of the test is to determine hormone secretion from the pancreas and small intestine in response to the mixed meal. Other Name: MMTT Diagnostic Test: Hemoglobin A1c This test provides the average level of blood glucose over the last 3 months. Other Names: Glycated Hemoglobin Test Glycosylated Hemoglobin Diagnostic Test: Other exploratory blood biomarkers Other exploratory blood biomarkers including cell free DNA and other markers in development
Pancreatic Cystic Neoplasm/Pancreatitis Must meet one of the following criteria: Pancreatic cystic neoplasm for which resection, endoscopic ultrasound or serial imaging has been recommended Chronic pancreatitis as defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist	Diagnostic Test: Hemoglobin A1c This test provides the average level of blood glucose over the last 3 months. Other Names: Glycated Hemoglobin Test Glycosylated Hemoglobin Diagnostic Test: Other exploratory blood biomarkers Other exploratory blood biomarkers including cell free DNA and other markers in development
Inherited Risk Must meet one of the following criteria: Two or more blood relatives with PDAC (includes 1st-3rd degree relatives as defined in Table 2) One 1st degree relative with PDAC diagnosed before age 60 Germline mutation associated with a higher than average risk of PDAC including but not limited to the following: Hereditary breast and ovarian cancer syndromes BRCA1, BRCA2, PALB2 Hereditary nonpolyposis colon cancer (Lynch) syndrome MLH1, MSH2, MSH6, PMS2 Familial adenomatous polyposis (APC) Familial atypical multiple melanoma and mole syndrome CKDN2a, p16 Peutz-Jeghers syndrome STK11 Ataxia-telangiectasia ATM Juvenile polyposis syndromes SMAD4, BMPR1A Li Fraumeni TP53 Cystic fibrosis and unaffected carriers CFTR Personal or family history which meets clinical criteria for a hereditary cancer syndrome and includes a relative with PDAC	Diagnostic Test: Hemoglobin A1c This test provides the average level of blood glucose over the last 3 months. Other Names: Glycated Hemoglobin Test Glycosylated Hemoglobin Diagnostic Test: Other exploratory blood biomarkers Other exploratory blood biomarkers including cell free DNA and other markers in development

Outcome Measures

Primary Outcome Measures :

Number of pancreas cancer cases diagnosed. [ Time Frame: 5 years ]
Biomarkers which may predict early pancreas cancer. [ Time Frame: 5 years ]
Result of MMTT which may indicate type 3c diabetes, which may be a risk factor for pancreas cancer. [ Time Frame: 5 years ]

Biospecimen Retention: Samples With DNA

Detection of early PDAC will ideally use clinical and/or biochemical markers of early disease in combination with novel imaging techniques which can identify disease much earlier than with current modalities. This protocol will focus on clinical symptoms and blood biomarkers described below and will allow the study of novel biomarkers in development using banked blood specimens.

Identifying individuals with new-onset diabetes and/or diabetes in the setting of chronic pancreatitis, and who have clear evidence of type 3c diabetes may allow for targeted screening of these individuals, with Mixed Meal Tolerance Test, for pancreatic cancer in light of the high risk of cancer in these individuals.

Blood may be analyzed for other markers, including those currently in development and those which may be developed in the future.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

In order to obtain a resource of clinical data and longitudinally obtained, annotated blood specimens and to develop an enriched population to prospectively evaluate a sensitive and specific biomarker, subjects from the following 3 groups at higher than average risk of PDAC will be recruited and enrolled.

New onset diabetes, high risk pre-diabetes Pancreatic cystic neoplasms and pancreatitis Familial risk

Criteria

Inclusion Criteria:

General inclusion criteria:

Age ≥19
Able to provide written, informed consent

Exclusion Criteria:

General exclusion criteria:

Personal history of PDAC
Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)
Pre-diabetes on metformin for ≥ 3 years

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568630

Contacts

Layout table for location contacts

Contact: Christina L Hoy, DNP	402-559-1577	christina.hoy@unmc.edu
Contact: Kelsey A Klute, MD	402-559-8500	kelsey.klute@unmc.edu

Locations

Layout table for location information

United States, Nebraska
Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198
Contact: Christina Hoy, DNP 402-559-1577 christina.hoy@unmc.edu

Sponsors and Collaborators

University of Nebraska

National Cancer Institute (NCI)

More Information

Publications:

Brat DJ, Lillemoe KD, Yeo CJ, Warfield PB, Hruban RH. Progression of pancreatic intraductal neoplasias to infiltrating adenocarcinoma of the pancreas. Am J Surg Pathol. 1998 Feb;22(2):163-9.

Yachida S, Jones S, Bozic I, Antal T, Leary R, Fu B, Kamiyama M, Hruban RH, Eshleman JR, Nowak MA, Velculescu VE, Kinzler KW, Vogelstein B, Iacobuzio-Donahue CA. Distant metastasis occurs late during the genetic evolution of pancreatic cancer. Nature. 2010 Oct 28;467(7319):1114-7. doi: 10.1038/nature09515.

Matthaei H, Hong SM, Mayo SC, dal Molin M, Olino K, Venkat R, Goggins M, Herman JM, Edil BH, Wolfgang CL, Cameron JL, Schulick RD, Maitra A, Hruban RH. Presence of pancreatic intraepithelial neoplasia in the pancreatic transection margin does not influence outcome in patients with R0 resected pancreatic cancer. Ann Surg Oncol. 2011 Nov;18(12):3493-9. doi: 10.1245/s10434-011-1745-9. Epub 2011 May 3.

Winter JM, Cameron JL, Campbell KA, Arnold MA, Chang DC, Coleman J, Hodgin MB, Sauter PK, Hruban RH, Riall TS, Schulick RD, Choti MA, Lillemoe KD, Yeo CJ. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg. 2006 Nov;10(9):1199-210; discussion 1210-1.

Pelaez-Luna M, Takahashi N, Fletcher JG, Chari ST. Resectability of presymptomatic pancreatic cancer and its relationship to onset of diabetes: a retrospective review of CT scans and fasting glucose values prior to diagnosis. Am J Gastroenterol. 2007 Oct;102(10):2157-63.

Gangi S, Fletcher JG, Nathan MA, Christensen JA, Harmsen WS, Crownhart BS, Chari ST. Time interval between abnormalities seen on CT and the clinical diagnosis of pancreatic cancer: retrospective review of CT scans obtained before diagnosis. AJR Am J Roentgenol. 2004 Apr;182(4):897-903.

Batabyal P, Vander Hoorn S, Christophi C, Nikfarjam M. Association of diabetes mellitus and pancreatic adenocarcinoma: a meta-analysis of 88 studies. Ann Surg Oncol. 2014 Jul;21(7):2453-62. doi: 10.1245/s10434-014-3625-6. Epub 2014 Mar 9.

Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11.

Kirkegård J, Mortensen FV, Cronin-Fenton D. Chronic Pancreatitis and Pancreatic Cancer Risk: A Systematic Review and Meta-analysis. Am J Gastroenterol. 2017 Sep;112(9):1366-1372. doi: 10.1038/ajg.2017.218. Epub 2017 Aug 1. Review.

Tanaka M, Chari S, Adsay V, Fernandez-del Castillo C, Falconi M, Shimizu M, Yamaguchi K, Yamao K, Matsuno S; International Association of Pancreatology. International consensus guidelines for management of intraductal papillary mucinous neoplasms and mucinous cystic neoplasms of the pancreas. Pancreatology. 2006;6(1-2):17-32. Review.

Klein AP, Brune KA, Petersen GM, Goggins M, Tersmette AC, Offerhaus GJ, Griffin C, Cameron JL, Yeo CJ, Kern S, Hruban RH. Prospective risk of pancreatic cancer in familial pancreatic cancer kindreds. Cancer Res. 2004 Apr 1;64(7):2634-8.

McWilliams RR, Rabe KG, Olswold C, De Andrade M, Petersen GM. Risk of malignancy in first-degree relatives of patients with pancreatic carcinoma. Cancer. 2005 Jul 15;104(2):388-94.

Brose MS, Rebbeck TR, Calzone KA, Stopfer JE, Nathanson KL, Weber BL. Cancer risk estimates for BRCA1 mutation carriers identified in a risk evaluation program. J Natl Cancer Inst. 2002 Sep 18;94(18):1365-72.

Breast Cancer Linkage Consortium. Cancer risks in BRCA2 mutation carriers. J Natl Cancer Inst. 1999 Aug 4;91(15):1310-6.

Murphy KM, Brune KA, Griffin C, Sollenberger JE, Petersen GM, Bansal R, Hruban RH, Kern SE. Evaluation of candidate genes MAP2K4, MADH4, ACVR1B, and BRCA2 in familial pancreatic cancer: deleterious BRCA2 mutations in 17%. Cancer Res. 2002 Jul 1;62(13):3789-93.

van Asperen CJ, Brohet RM, Meijers-Heijboer EJ, Hoogerbrugge N, Verhoef S, Vasen HF, Ausems MG, Menko FH, Gomez Garcia EB, Klijn JG, Hogervorst FB, van Houwelingen JC, van't Veer LJ, Rookus MA, van Leeuwen FE; Netherlands Collaborative Group on Hereditary Breast Cancer (HEBON). Cancer risks in BRCA2 families: estimates for sites other than breast and ovary. J Med Genet. 2005 Sep;42(9):711-9.

Jones S, Hruban RH, Kamiyama M, Borges M, Zhang X, Parsons DW, Lin JC, Palmisano E, Brune K, Jaffee EM, Iacobuzio-Donahue CA, Maitra A, Parmigiani G, Kern SE, Velculescu VE, Kinzler KW, Vogelstein B, Eshleman JR, Goggins M, Klein AP. Exomic sequencing identifies PALB2 as a pancreatic cancer susceptibility gene. Science. 2009 Apr 10;324(5924):217. doi: 10.1126/science.1171202. Epub 2009 Mar 5.

Hofstatter EW, Domchek SM, Miron A, Garber J, Wang M, Componeschi K, Boghossian L, Miron PL, Nathanson KL, Tung N. PALB2 mutations in familial breast and pancreatic cancer. Fam Cancer. 2011 Jun;10(2):225-31. doi: 10.1007/s10689-011-9426-1.

Bujanda L, Herreros-Villanueva M. Pancreatic Cancer in Lynch Syndrome Patients. J Cancer. 2017 Oct 11;8(18):3667-3674. doi: 10.7150/jca.20750. eCollection 2017. Review.

Giardiello FM, Offerhaus GJ, Lee DH, Krush AJ, Tersmette AC, Booker SV, Kelley NC, Hamilton SR. Increased risk of thyroid and pancreatic carcinoma in familial adenomatous polyposis. Gut. 1993 Oct;34(10):1394-6.

Whitcomb DC, Applebaum S, Martin SP. Hereditary pancreatitis and pancreatic carcinoma. Ann N Y Acad Sci. 1999 Jun 30;880:201-9.

Rebours V, Boutron-Ruault MC, Schnee M, Férec C, Maire F, Hammel P, Ruszniewski P, Lévy P. Risk of pancreatic adenocarcinoma in patients with hereditary pancreatitis: a national exhaustive series. Am J Gastroenterol. 2008 Jan;103(1):111-9. doi: 10.1111/j.1572-0241.2007.01597.x.

Howes N, Lerch MM, Greenhalf W, Stocken DD, Ellis I, Simon P, Truninger K, Ammann R, Cavallini G, Charnley RM, Uomo G, Delhaye M, Spicak J, Drumm B, Jansen J, Mountford R, Whitcomb DC, Neoptolemos JP; European Registry of Hereditary Pancreatitis and Pancreatic Cancer (EUROPAC). Clinical and genetic characteristics of hereditary pancreatitis in Europe. Clin Gastroenterol Hepatol. 2004 Mar;2(3):252-61.

Lowenfels AB, Maisonneuve P, DiMagno EP, Elitsur Y, Gates LK Jr, Perrault J, Whitcomb DC. Hereditary pancreatitis and the risk of pancreatic cancer. International Hereditary Pancreatitis Study Group. J Natl Cancer Inst. 1997 Mar 19;89(6):442-6.

Lynch HT, Fusaro RM, Lynch JF, Brand R. Pancreatic cancer and the FAMMM syndrome. Fam Cancer. 2008;7(1):103-12. Epub 2007 Nov 9. Review.

Vasen HF, Gruis NA, Frants RR, van Der Velden PA, Hille ET, Bergman W. Risk of developing pancreatic cancer in families with familial atypical multiple mole melanoma associated with a specific 19 deletion of p16 (p16-Leiden). Int J Cancer. 2000 Sep 15;87(6):809-11.

Giardiello FM, Brensinger JD, Tersmette AC, Goodman SN, Petersen GM, Booker SV, Cruz-Correa M, Offerhaus JA. Very high risk of cancer in familial Peutz-Jeghers syndrome. Gastroenterology. 2000 Dec;119(6):1447-53.

Roberts NJ, Jiao Y, Yu J, Kopelovich L, Petersen GM, Bondy ML, Gallinger S, Schwartz AG, Syngal S, Cote ML, Axilbund J, Schulick R, Ali SZ, Eshleman JR, Velculescu VE, Goggins M, Vogelstein B, Papadopoulos N, Hruban RH, Kinzler KW, Klein AP. ATM mutations in patients with hereditary pancreatic cancer. Cancer Discov. 2012 Jan;2(1):41-6. doi: 10.1158/2159-8290.CD-11-0194. Epub 2011 Dec 29.

Swift M, Morrell D, Massey RB, Chase CL. Incidence of cancer in 161 families affected by ataxia-telangiectasia. N Engl J Med. 1991 Dec 26;325(26):1831-6.

Syngal S, Brand RE, Church JM, Giardiello FM, Hampel HL, Burt RW; American College of Gastroenterology. ACG clinical guideline: Genetic testing and management of hereditary gastrointestinal cancer syndromes. Am J Gastroenterol. 2015 Feb;110(2):223-62; quiz 263. doi: 10.1038/ajg.2014.435. Epub 2015 Feb 3. Review.

McWilliams R, Highsmith WE, Rabe KG, de Andrade M, Tordsen LA, Holtegaard LM, Petersen GM. Cystic fibrosis transmembrane regulator gene carrier status is a risk factor for young onset pancreatic adenocarcinoma. Gut. 2005 Nov;54(11):1661-2.

Pannala R, Leirness JB, Bamlet WR, Basu A, Petersen GM, Chari ST. Prevalence and clinical profile of pancreatic cancer-associated diabetes mellitus. Gastroenterology. 2008 Apr;134(4):981-7. doi: 10.1053/j.gastro.2008.01.039. Epub 2008 Jan 18.

Hruban RH, Takaori K, Klimstra DS, Adsay NV, Albores-Saavedra J, Biankin AV, Biankin SA, Compton C, Fukushima N, Furukawa T, Goggins M, Kato Y, Klöppel G, Longnecker DS, Lüttges J, Maitra A, Offerhaus GJ, Shimizu M, Yonezawa S. An illustrated consensus on the classification of pancreatic intraepithelial neoplasia and intraductal papillary mucinous neoplasms. Am J Surg Pathol. 2004 Aug;28(8):977-87. Review.

Longnecker DS, Adsay NV, Fernandez-del Castillo C, Hruban RH, Kasugai T, Klimstra DS, Klöppel G, Lüttges J, Memoli VA, Tosteson TD, Yanagisawa A, Wilentz R, Zamboni G. Histopathological diagnosis of pancreatic intraepithelial neoplasia and intraductal papillary-mucinous neoplasms: interobserver agreement. Pancreas. 2005 Nov;31(4):344-9.

Scheiman JM, Hwang JH, Moayyedi P. American gastroenterological association technical review on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. 2015 Apr;148(4):824-48.e22. doi: 10.1053/j.gastro.2015.01.014. Review.

Klibansky DA, Reid-Lombardo KM, Gordon SR, Gardner TB. The clinical relevance of the increasing incidence of intraductal papillary mucinous neoplasm. Clin Gastroenterol Hepatol. 2012 May;10(5):555-8. doi: 10.1016/j.cgh.2011.12.029. Epub 2011 Dec 28.

Vege SS, Ziring B, Jain R, Moayyedi P; Clinical Guidelines Committee; American Gastroenterology Association. American gastroenterological association institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. 2015 Apr;148(4):819-22; quize12-3. doi: 10.1053/j.gastro.2015.01.015.

Klein AP. Genetic susceptibility to pancreatic cancer. Mol Carcinog. 2012 Jan;51(1):14-24. doi: 10.1002/mc.20855.

Shindo K, Yu J, Suenaga M, Fesharakizadeh S, Cho C, Macgregor-Das A, Siddiqui A, Witmer PD, Tamura K, Song TJ, Navarro Almario JA, Brant A, Borges M, Ford M, Barkley T, He J, Weiss MJ, Wolfgang CL, Roberts NJ, Hruban RH, Klein AP, Goggins M. Deleterious Germline Mutations in Patients With Apparently Sporadic Pancreatic Adenocarcinoma. J Clin Oncol. 2017 Oct 20;35(30):3382-3390. doi: 10.1200/JCO.2017.72.3502. Epub 2017 Aug 2.

Ewald N, Kaufmann C, Raspe A, Kloer HU, Bretzel RG, Hardt PD. Prevalence of diabetes mellitus secondary to pancreatic diseases (type 3c). Diabetes Metab Res Rev. 2012 May;28(4):338-42. doi: 10.1002/dmrr.2260.

Hart PA, Baichoo E, Bi Y, Hinton A, Kudva YC, Chari ST. Pancreatic polypeptide response to a mixed meal is blunted in pancreatic head cancer associated with diabetes mellitus. Pancreatology. 2015 Mar-Apr;15(2):162-6. doi: 10.1016/j.pan.2015.02.006. Epub 2015 Feb 24.

Rickels MR, Bellin M, Toledo FG, Robertson RP, Andersen DK, Chari ST, Brand R, Frulloni L, Anderson MA, Whitcomb DC; PancreasFest Recommendation Conference Participants. Detection, evaluation and treatment of diabetes mellitus in chronic pancreatitis: recommendations from PancreasFest 2012. Pancreatology. 2013 Jul-Aug;13(4):336-42. doi: 10.1016/j.pan.2013.05.002. Epub 2013 May 17.

Ewald N, Bretzel RG. Diabetes mellitus secondary to pancreatic diseases (Type 3c)--are we neglecting an important disease? Eur J Intern Med. 2013 Apr;24(3):203-6. doi: 10.1016/j.ejim.2012.12.017. Epub 2013 Feb 1. Review.

Škrha J, Bušek P, Uhrová J, Hrabal P, Kmochová K, Laclav M, Bunganič B, Frič P. Lower plasma levels of glucose-dependent insulinotropic peptide (GIP) and pancreatic polypeptide (PP) in patients with ductal adenocarcinoma of the pancreas and their relation to the presence of impaired glucoregulation and weight loss. Pancreatology. 2017 Jan - Feb;17(1):89-94. doi: 10.1016/j.pan.2016.12.004. Epub 2016 Dec 15.

Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122. Review.

Cohen JD, Javed AA, Thoburn C, Wong F, Tie J, Gibbs P, Schmidt CM, Yip-Schneider MT, Allen PJ, Schattner M, Brand RE, Singhi AD, Petersen GM, Hong SM, Kim SC, Falconi M, Doglioni C, Weiss MJ, Ahuja N, He J, Makary MA, Maitra A, Hanash SM, Dal Molin M, Wang Y, Li L, Ptak J, Dobbyn L, Schaefer J, Silliman N, Popoli M, Goggins MG, Hruban RH, Wolfgang CL, Klein AP, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Lennon AM. Combined circulating tumor DNA and protein biomarker-based liquid biopsy for the earlier detection of pancreatic cancers. Proc Natl Acad Sci U S A. 2017 Sep 19;114(38):10202-10207. doi: 10.1073/pnas.1704961114. Epub 2017 Sep 5.

Li J, Dittmar RL, Xia S, Zhang H, Du M, Huang CC, Druliner BR, Boardman L, Wang L. Cell-free DNA copy number variations in plasma from colorectal cancer patients. Mol Oncol. 2017 Aug;11(8):1099-1111. doi: 10.1002/1878-0261.12077. Epub 2017 Jun 6.

Kaur S, Smith LM, Patel A, Menning M, Watley DC, Malik SS, Krishn SR, Mallya K, Aithal A, Sasson AR, Johansson SL, Jain M, Singh S, Guha S, Are C, Raimondo M, Hollingsworth MA, Brand RE, Batra SK. A Combination of MUC5AC and CA19-9 Improves the Diagnosis of Pancreatic Cancer: A Multicenter Study. Am J Gastroenterol. 2017 Jan;112(1):172-183. doi: 10.1038/ajg.2016.482. Epub 2016 Nov 15.

Yue T, Maupin KA, Fallon B, Li L, Partyka K, Anderson MA, Brenner DE, Kaul K, Zeh H, Moser AJ, Simeone DM, Feng Z, Brand RE, Haab BB. Enhanced discrimination of malignant from benign pancreatic disease by measuring the CA 19-9 antigen on specific protein carriers. PLoS One. 2011;6(12):e29180. doi: 10.1371/journal.pone.0029180. Epub 2011 Dec 29.

Kim J, Bamlet WR, Oberg AL, Chaffee KG, Donahue G, Cao XJ, Chari S, Garcia BA, Petersen GM, Zaret KS. Detection of early pancreatic ductal adenocarcinoma with thrombospondin-2 and CA19-9 blood markers. Sci Transl Med. 2017 Jul 12;9(398). pii: eaah5583. doi: 10.1126/scitranslmed.aah5583.

Friedman J, Hastie T, Tibshirani R. Regularization Paths for Generalized Linear Models via Coordinate Descent. J Stat Softw. 2010;33(1):1-22.

Canto MI, Harinck F, Hruban RH, Offerhaus GJ, Poley JW, Kamel I, Nio Y, Schulick RS, Bassi C, Kluijt I, Levy MJ, Chak A, Fockens P, Goggins M, Bruno M; International Cancer of Pancreas Screening (CAPS) Consortium. International Cancer of the Pancreas Screening (CAPS) Consortium summit on the management of patients with increased risk for familial pancreatic cancer. Gut. 2013 Mar;62(3):339-47. doi: 10.1136/gutjnl-2012-303108. Epub 2012 Nov 7. Erratum in: Gut. 2014 Dec;63(12):1978. Hammell, Pascal [corrected to Hammel, Pascal]. Gut. 2014 Jan;63(1):178. Hamell, Pascal [corrected to Hammell, Pascal].

Layout table for additonal information

Responsible Party:	Kelsey Klute, MD, Assistant Professor, Internal Medicine Oncology/Hematology, University of Nebraska
ClinicalTrials.gov Identifier:	NCT03568630 History of Changes
Other Study ID Numbers:	335-18
First Posted:	June 25, 2018 Key Record Dates
Last Update Posted:	November 19, 2018
Last Verified:	November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	The Pancreatic Cancer Detection Consortium (PCDC) includes collaborators at several institutions, including UNMC, working to identify biomarkers and develop novel imaging techniques to identify pre-malignant and subclinical PDAC. One of the primary objectives of the consortium is to establish a repository of serial biospecimens collected from subjects prior to their diagnosis of PDAC. These specimens will be readily available when biomarkers in development are ready for validation. Due to the low incidence of pancreas cancer, even in groups at substantially increased risk, obtaining enough specimens to use for biomarker identification from those subjects who go on to develop PDAC requires collaborative effort between multiple institutions. This proposal is the contribution from UNMC to the consortium's biorepository effort.
Time Frame:	Data will be shared with the consortium on a rolling basis throughout the enrollment period.
Access Criteria:	Priority will be given to researchers affiliated with the PCDC. Primary investigators will review outside requests, which may be accepted on a case by case basis.

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Layout table for MeSH terms

Diabetes Mellitus Diabetes Mellitus, Type 2 Pancreatitis Prediabetic State Pancreatitis, Chronic Pancreatic Neoplasms Disease Susceptibility Genetic Predisposition to Disease Pancreatic Cyst Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Pancreatic Diseases Digestive System Diseases Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Disease Attributes Pathologic Processes Cysts Pancrelipase Pancreatin Gastrointestinal Agents

To Top