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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01CA210170-01 | U.S. NIH Grant/Contract | View source | |
| R01CA176828 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
| American Association for Cancer Research | OTHER |
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Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.
The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Familial pancreas cancer relatives | Active Comparator | High Risk Group 2 (familial pancreatic cancer relatives):
If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened |
|
| Group 1 germline mutation carrier | Active Comparator | High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher): a. > 50 years old or 10 years younger than the age of the youngest relative affected, if pancreatic cancer is in family, and b. The Patient is a carrier of a confirmed BRCA2, ATM or PALB2 mutation, regardless of family history of pancreatic cancer. b.> Individual is a carrier of a confirmed FAMMM (p16/CDKN2A) mutation, age 40 years or older, regardless of family history of pancreas cancer. |
|
| Group 2 germline mutation carrier | Active Comparator | High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%):
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secretin | Drug | inject Secretin to stimulate pancreatic digestive fluid, which is collected in duodenum near ampulla via endoscope suction port. This fluid will be assessed for biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate pancreatic juice for early cancer markers. | Aim #1: To evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Compare pancreas juice with pancreas cyst fluid | Aim #2: To compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time disease progression and prevalence | Aim #3: To determine the prevalence of pancreatic lesions, pancreatic fluid mutations and circulating pancreatic epithelial cells among a large cohort of high-risk individuals undergoing pancreatic screening and surveillance of a new cohort in which screening is begun at age >55. | 10 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hilary Cosby, RN | Contact | hcosby1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Goggins, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34149034 | Derived | Kumar S, Saumoy M, Oh A, Schneider Y, Brand RE, Chak A, Ginsberg GG, Kochman ML, Canto MI, Goggins MG, Hur C, Kastrinos F, Katona BW, Rustgi AK. Threshold Analysis of the Cost-effectiveness of Endoscopic Ultrasound in Patients at High Risk for Pancreatic Ductal Adenocarcinoma. Pancreas. 2021 Jul 1;50(6):807-814. doi: 10.1097/MPA.0000000000001835. | |
| 33161160 | Derived | Kohi S, Macgregor-Das A, Dbouk M, Yoshida T, Chuidian M, Abe T, Borges M, Lennon AM, Shin EJ, Canto MI, Goggins M. Alterations in the Duodenal Fluid Microbiome of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e196-e227. doi: 10.1016/j.cgh.2020.11.006. Epub 2020 Nov 5. |
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Evaluation of the effect of diagnostic tests for pancreatic cancer
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No masking of the diagnostic test results
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|
| Hereditary pancreatitis | Active Comparator | High risk group 5 (hereditary pancreatitis) with confirmed gene mutations that predispose to chronic pancreatitis, such as PRSS1, PRSS2, CTRC) and age 50 years or older (these patients have an estimated lifetime risk for pancreatic cancer of 40%) or twenty-years since their first attack of pancreatitis, whichever age is younger. |
|
| Peutz-Jeghers Syndrome | Active Comparator |
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| Negative control | Active Comparator |
|
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| Chronic Pancreatitis | Active Comparator |
|
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| Pancreas cancer | Active Comparator | a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence) |
|
| Pancreas cyst, IPMN evaluation | Active Comparator | are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic cancer precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct and/or pancreatic cystic lesion communicating with the pancreatic ductal system). |
|
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| MRI | Diagnostic Test | MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results. |
|
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| Tumor marker gene test with CA19-9 | Other | A tumor marker gene test that will be used to stratify individuals into one of several circulating tumor marker reference ranges for CA19-9. The variants in the genes FUT3 and FUT2 affect the levels of CA19-9. |
|
| Diagnostic performance of a tumor marker gene test for CA19-9 interpretation |
Aim #4 To evaluate the diagnostic performance of a tumor marker gene test to personalize the normal reference range of tumor markers such as CA19-9 for patients undergoing pancreatic surveillance. |
| 5 years |
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| Dana Farber Cancer Center, Harvard University | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| NYU Langone Medical Center | Recruiting | New York | New York | 10016 | United States |
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| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
|
| Case Comprehensive Cancer Center, Case Western Medical Reserve | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| 31676359 | Derived | Abe T, Koi C, Kohi S, Song KB, Tamura K, Macgregor-Das A, Kitaoka N, Chuidian M, Ford M, Dbouk M, Borges M, He J, Burkhart R, Wolfgang CL, Klein AP, Eshleman JR, Hruban RH, Canto MI, Goggins M. Gene Variants That Affect Levels of Circulating Tumor Markers Increase Identification of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2020 May;18(5):1161-1169.e5. doi: 10.1016/j.cgh.2019.10.036. Epub 2019 Oct 30. |
| 31197699 | Derived | Canto MI, Kerdsirichairat T, Yeo CJ, Hruban RH, Shin EJ, Almario JA, Blackford A, Ford M, Klein AP, Javed AA, Lennon AM, Zaheer A, Kamel IR, Fishman EK, Burkhart R, He J, Makary M, Weiss MJ, Schulick RD, Goggins MG, Wolfgang CL. Surgical Outcomes After Pancreatic Resection of Screening-Detected Lesions in Individuals at High Risk for Developing Pancreatic Cancer. J Gastrointest Surg. 2020 May;24(5):1101-1110. doi: 10.1007/s11605-019-04230-z. Epub 2019 Jun 13. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010580 | Peutz-Jeghers Syndrome |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| D001943 | Breast Neoplasms |
| D004416 | Dysplastic Nevus Syndrome |
| C537262 | Hereditary pancreatitis |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009386 | Neoplastic Syndromes, Hereditary |
| D044483 | Intestinal Polyposis |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007911 | Lentigo |
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D003108 | Colonic Diseases |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001941 | Breast Diseases |
| D009506 | Nevus |
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D012633 | Secretin |
| D018395 | CA-19-9 Antigen |
| ID | Term |
|---|---|
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D015295 | Antigens, Tumor-Associated, Carbohydrate |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D007983 | Lewis Blood Group Antigens |
| D001789 | Blood Group Antigens |
| D000954 | Antigens, Surface |
| D000939 | Epitopes |
| D007519 | Isoantigens |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |
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