Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study) (CAPS4)

Tracking Information
First Submitted Date	July 9, 2008
First Posted Date	July 14, 2008
Last Update Posted Date	March 22, 2017
Study Start Date	June 2008
Actual Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: July 11, 2008)	This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals. [ Time Frame: 5 years ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00714701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)
Official Title	Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)
Brief Summary	CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of screening patients with an increased inherited risk for pancreatic cancer.
Detailed Description	Pancreatic cancer is a deadly disease and the only hope for improvement of survival is early detection. Certain genetic syndromes are associated with a high risk of pancreatic cancer and screening for pancreatic cancer has become a relatively new strategy for familial pancreatic cancer. . Our pancreatic cancer research group at Johns Hopkins and others have shown that screening with EUS and/or abdominal imaging tests such as CT/MRI can detect a relatively high number of significant pancreatic neoplasms (7-18%) in asymptomatic high risk individuals with an inherited predisposition for pancreatic ductal adenocarcinoma This is a clinical, early detection translational study that will directly influence patient care. This long term study follows the successful completion of single center Cancer of the Pancreas (CAPS) 1 and CAPS 2 studies at Johns Hopkins, and the ongoing CAPS 3 multicenter study. GENERAL AIM: This is a study that aims to evaluate the diagnostic yield, quality of life, and clinical outcomes of a clinical screening and surveillance program for individuals at-risk for pancreatic cancer and to validate a candidate panel of biomarkers for early detection of pancreatic neoplasia. The 3 specific groups to be screened and followed are individuals from familial pancreatic cancer kindreds (who have 2 or more affected relatives and have an estimated risk 16-57 times that of controls), patients with familial Peutz-Jeghers syndrome, patients with a known BRCA-2, BRCA-1, PALB2, PRSS or p16 germline mutation.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: blood, pancreatic juices
Sampling Method	Probability Sample
Study Population	asymptomatic high risk patients
Condition	Early Pancreatic Neoplasia; Familial Pancreatic Neoplasia
Intervention	Not Provided
Study Groups/Cohorts	High Risk Group 1 familial Peutz-Jeghers syndrome; High Risk Group 2 familial pancreatic cancer relatives; High Risk Group 3 germline mutation carriers BRCA1, BRCA2, PRSS, PALB2, p16; High Risk Group 4 young-onset pancreatic cancer relative; High Risk Group 5 both parents affected; Control 1 negative controls; Control 2 chronic pancreatitis; Control 3 pancreatic cancer; Control 4 intraductal papillary mucinous neoplasm (IPMN)
Publications *	Eshleman JR, Norris AL, Sadakari Y, Debeljak M, Borges M, Harrington C, Lin E, Brant A, Barkley T, Almario JA, Topazian M, Farrell J, Syngal S, Lee JH, Yu J, Hruban RH, Kanda M, Canto MI, Goggins M. KRAS and guanine nucleotide-binding protein mutations in pancreatic juice collected from the duodenum of patients at high risk for neoplasia undergoing endoscopic ultrasound. Clin Gastroenterol Hepatol. 2015 May;13(5):963-9.e4. doi: 10.1016/j.cgh.2014.11.028. Epub 2014 Dec 4.; Kanda M, Sadakari Y, Borges M, Topazian M, Farrell J, Syngal S, Lee J, Kamel I, Lennon AM, Knight S, Fujiwara S, Hruban RH, Canto MI, Goggins M. Mutant TP53 in duodenal samples of pancreatic juice from patients with pancreatic cancer or high-grade dysplasia. Clin Gastroenterol Hepatol. 2013 Jun;11(6):719-30.e5. doi: 10.1016/j.cgh.2012.11.016. Epub 2012 Nov 28.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: March 21, 2017)	631
Original Estimated Enrollment; (submitted: July 11, 2008)	240
Actual Study Completion Date	July 2016
Actual Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: High Risk Group 1 (familial Peutz-Jeghers syndrome): At least 30 years old and <100 years old, and at least 2 of 3 criteria diagnostic of Peutz-Jeghers syndrome (characteristic intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family history of Peutz-Jeghers syndrome) known STK-11 gene mutation carrier; High Risk Group 2 (familial pancreatic cancer relatives): > 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and have a first-degree relationship with at least one of the relatives with pancreatic cancer. If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened; High Risk Group 3 (germline mutation carriers): > 40 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old patient is carrier of a known BRCA1, BRCA2, PALB2, or FAMMM (p16/CDKN2A) mutation, and there is > 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened. Hereditary pancreatitis syndrome; High Risk Group 4 (young-onset pancreatic cancer relative): > 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old have a first-degree relationship with at least one relative with young-onset pancreatic cancer ( age of onset < 50 years); High risk group 5 (both parents affected) > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old two parents affected by pancreatic cancer; Control 1 (Negative Controls): are undergoing EUS and/or ERCP for non-pancreatic indications as part of their standard medical care, and have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer); Control 2 (Chronic Pancreatitis) are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven chronic pancreatitis as part of their standard medical care, and, have no clinical or radiologic suspicion of pancreatic cancer; Control 3 (Pancreatic Cancer) 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); Control 4 (Intraductal Papillary Mucinous Neoplasm or IPMN) a. 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) Additional requirements for eligible high risk patients: i) All persons with known genetic mutation must have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory. ii) A good faith attempt should be made to confirm pancreatic cancers in the family members via registration in a pancreatic cancer registry iii) The affected first degree relative of the person being screened must be confirmed by medical record or death certificate. All control patients must be > 18 and < 80 years old and no personal or family history of pancreatic cancer or a germline mutation linked to pancreatic cancer. Exclusion Criteria: Patients will be excluded if they have any of the following: medical comorbidities or coagulopathy that contraindicate endoscopy,; Karnosfky performance status of < 60,; had partial or complete resection of their pancreas; had a partial or complete gastrectomy with Billroth or Roux-en-Y anastomosis; a stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope; life expectancy less than 5 years due to coexisting advanced cancer or AIDS.; inability to provide informed consent; pregnant patient; history of pancreatic cancer,; suspicion of pancreatic neoplasia based on clinical history (weight loss, unexplained abdominal pain), physical examination (obstructive jaundice, cachexia), laboratory tests (cholestastic liver function tests, markedly elevated CA19-9), and/or imaging studies (pancreatic mass or cyst, dilated pancreatic and/or bile duct);; there is no interest in undergoing treatment of pancreatic neoplasm(s) detected by screening.; history of chronic kidney disease, serum creatinine > 2.0 mg/dl or estimated glomerulofiltration rate (eGFR) < 30 ml/min, ongoing acute renal failure, cirrhosis of the liver, chronic hepatitis (The estimated glomerulfiltration rate (eGFR) will be calculated based on age, race, and serum creatinine, using the on-line calculator at nephron.com).; history of dementia
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 100 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00714701
Other Study ID Numbers	J0139 00-04-14-10; J0139
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: This study data is part of the CAPS Consortium Registry, an International registry for people screened for pancreas cancer.
Responsible Party	Sidney Kimmel Comprehensive Cancer Center
Study Sponsor	Sidney Kimmel Comprehensive Cancer Center
Collaborators	The V Foundation for Cancer Research; ChiRhoClin, Inc.
Investigators	Principal Investigator: Marcia Irene F. Canto, MD, MHS Johns Hopkins University
PRS Account	Sidney Kimmel Comprehensive Cancer Center
Verification Date	March 2017