The Cancer of the Pancreas Screening-5 CAPS5)Study

Johns Hopkins University

Status and phase: Enrolling; Phase 3

Conditions: Lynch Syndrome; Germline Mutation Carrier; Peutz-Jeghers Syndrome (PJS); Pancreas Cancer; Gene Mutation

Treatments: Other: Tumor marker gene test with CA19-9; Drug: Secretin; Diagnostic Test: MRI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02000089

1U01CA210170-01 (U.S. NIH Grant/Contract)

R01CA176828 (U.S. NIH Grant/Contract)

NA_00087754

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hereditary Pancreatitis or
• Peutz-Jeghers Syndrome or
• Strong family history of pancreas cancer on one side of the family tree or
• Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR
• Endoscopic evaluation of pancreas scheduled

Exclusion criteria

• Medical comorbidities or coagulopathy that contraindicate endoscopy
• Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
• Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
• Poor performance status
• Inability to provide informed consent
• Pregnancy.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9,000 participants in 9 patient groups

Familial pancreas cancer relatives

Active Comparator group

Description:

High Risk Group 2 (familial pancreatic cancer relatives): 1. \> 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and 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

Treatment:

Diagnostic Test: MRI

Drug: Secretin

Other: Tumor marker gene test with CA19-9

Group 1 germline mutation carrier

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: MRI

Drug: Secretin

Other: Tumor marker gene test with CA19-9

Group 2 germline mutation carrier

Active Comparator group

Description:

High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \~5%): 1. \> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and 2. The patient is a carrier of a confirmed BRCA1 or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene 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.

Treatment:

Diagnostic Test: MRI

Drug: Secretin

Other: Tumor marker gene test with CA19-9

Hereditary pancreatitis

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: MRI

Drug: Secretin

Other: Tumor marker gene test with CA19-9

Peutz-Jeghers Syndrome

Active Comparator group

Description:

1. At least 30 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), or, 3. known STK11 gene mutation carrier

Treatment:

Diagnostic Test: MRI

Drug: Secretin

Other: Tumor marker gene test with CA19-9

Negative control

Active Comparator group

Description:

1. are undergoing routine EGD or Colonoscopy; or Endoscopic Ultrasound (EUS) and/or Endoscopic Retrograde Cholangiopancreatography (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)

Treatment:

Drug: Secretin

Chronic Pancreatitis

Active Comparator group

Description:

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

Treatment:

Drug: Secretin

Pancreas cancer

Active Comparator group

Description:

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)

Treatment:

Drug: Secretin

Pancreas cyst, IPMN evaluation

Active Comparator group

Description:

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).

Treatment:

Drug: Secretin