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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborators:
The V Foundation for Cancer Research
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00714701
First received: July 9, 2008
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition
Early Pancreatic Neoplasia
Familial Pancreatic Neoplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood, pancreatic juices


Estimated Enrollment: 900
Study Start Date: June 2008
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

asymptomatic high risk patients

Criteria

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 proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)

  9. 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:

  1. medical comorbidities or coagulopathy that contraindicate endoscopy,
  2. Karnosfky performance status of < 60,
  3. had partial or complete resection of their pancreas
  4. had a partial or complete gastrectomy with Billroth or Roux-en-Y anastomosis
  5. a stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
  6. life expectancy less than 5 years due to coexisting advanced cancer or AIDS.
  7. inability to provide informed consent
  8. pregnant patient
  9. history of pancreatic cancer,
  10. 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);
  11. there is no interest in undergoing treatment of pancreatic neoplasm(s) detected by screening.
  12. 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).
  13. history of dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714701

Contacts
Contact: Hilary Cosby, RN 410-502-2893 hcosby1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Marcia Irene F. Canto, MD, MHS         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
The V Foundation for Cancer Research
ChiRhoClin, Inc.
Investigators
Principal Investigator: Marcia Irene F. Canto, MD, MHS Johns Hopkins Medicine
  More Information

No publications provided by Sidney Kimmel Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00714701     History of Changes
Obsolete Identifiers: NCT00084357
Other Study ID Numbers: J0139 00-04-14-10, J0139
Study First Received: July 9, 2008
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014