Status:
COMPLETED
Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
The V Foundation for Cancer Research
ChiRhoClin, Inc.
Conditions:
Early Pancreatic Neoplasia
Familial Pancreatic Neoplasia
Eligibility:
All Genders
18-100 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
631 Patients enrolled
Trial Details
Trial ID
NCT00714701
Start Date
June 1 2008
End Date
July 1 2016
Last Update
September 7 2018
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205