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

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Arm public domain (ClinicalTrials.gov)

High Risk Group 1 (): familial Peutz-Jeghers syndrome

Arm public domain (ClinicalTrials.gov)

High Risk Group 2 (): familial pancreatic cancer relatives

Arm public domain (ClinicalTrials.gov)

High Risk Group 3 (): germline mutation carriers BRCA1, BRCA2, PRSS, PALB2, p16

Arm public domain (ClinicalTrials.gov)

High Risk Group 4 (): young-onset pancreatic cancer relative

Arm public domain (ClinicalTrials.gov)

High Risk Group 5 (): both parents affected

Arm public domain (ClinicalTrials.gov)

Control 1 (): negative controls

Primary outcome public domain (ClinicalTrials.gov)

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.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: 1. High Risk Group 1 (familial Peutz-Jeghers syndrome): 1. At least 30 years old and \<100 years old, and 2. 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) 3. known STK-11 gene mutation carrier 2. High Risk Group 2 (familial pancreatic cancer relatives): 1. \> 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and \< 80 years old 2. 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 3. 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 3. High Risk Group 3 (germline mutation carriers): 1. \> 40 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and\< 80 years old 2. 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. 3. Hereditary pancreatitis syndrome 4. High Risk Group 4 (young-onset pancreatic cancer relative): 1. \> 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and \< 80 years old 2. have a first-degree relationship with at least one relative with young-onset pancreatic cancer ( age of onset \< 50 years) 5. High risk group 5 (both parents affected) 1. \> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and\< 80 years old 2. two parents affected by pancreatic cancer 6. Control 1 (Negative Controls): 1. are undergoing EUS and/or ERCP for non-pancreatic indications as part of their standard medical care, and 2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer) 7. Control 2 (Chronic Pancreatitis) 1. 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, 2. have no clinical or radiologic suspicion of pancreatic cancer 8. Control 3 (Pancreatic Cancer) a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 631 participants (actual).