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

NCT00714701 | Completed

• 2 other identifiers: J0139 00-04-14-10J0139
• Study Type: observational
• Target: 631
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Pancreatic Neoplasia; Familial Pancreatic Neoplasia

Outcome Measures

Primary Outcomes (1)

• This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals.

  5 years

Study Arms (9)

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)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

asymptomatic high risk patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• The V Foundation for Cancer Research: collaborator
• ChiRhoClin, Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 25481712 DERIVED

• 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.

  PMID: 23200980 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, pancreatic juices

Study Officials

• Marcia Irene F. Canto, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 14, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)