RECRUITING

Pancreatic Cancer Screening for At-risk Individuals

Conditions

Pancreatic Cancer, Adult Pancreatic cancer screening Early detection of pancreatic cancer Genetic susceptibility to pancreatic cancer BRCA 1 BRCA 2 familial pancreatic cancer Endoscopic Ultrasound MRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. We plan to use International Cancer of the Pancreas Screening (CAPS3) Consortium recommendations to standardize study population, screening methodology, and study outcomes.

Official Title

Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)

Quick Facts

Study Start:2020-07-10

Study Completion:2032-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05006131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Inclusion criteria 1-3 are indications for pancreatic cancer screening as defined by the CAPS3 guidelines or updated national pancreatic cancer screening guidelines. Patients who do not meet these guidelines but are undergoing pancreatic cancer screening at the discretion of their treating physician at participating study centers will also be included in the study. Based upon the indication for screening, patients will be categorized as either meeting CAPS3 screening criteria, or not meeting CAPS3 screening criteria. 1. Familial Pancreatic cancer kindred. This is defined as family history of pancreas cancer that meet the criteria listed below. 1. If at least two affected relatives who are First degree relatives (FDR) to each other, of whom at least one is an FDR to the individual considered for surveillance 2. If at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance 3. If at least two affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance Screening is usually initialed at age 50 years or 10 years younger than the youngest family member with pancreatic cancer 2. Patients with genetic susceptibility to pancreas cancer 1. Patients with Peutz-Jeghers syndrome diagnosed with using clinical criteria or with a deleterious mutation in liver kinase B1/Serine/threonine kinase 11 (LKB1/STK11). Screening is usually initiated at age 40 years or later. 2. Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM syndrome), diagnosed using clinical criteria or CDKN2A p16 mutation. 1. Hereditary Breast and Ovarian Cancer syndrome: diagnosed using clinical criteria or deleterious Breast Cancer gene 1 (BRCA1), Breast Cancer gene 2 (BRCA2), Partner and Localizer of BRCA2 (PALB2). The usual indication for screening is: * BRCA1 mutation and at least one affected first-degree relative with pancreatic cancer * BRCA 2 mutation and at least one affected first-degree relative, or at least two relatives of any degree with pancreatic cancer * PALB2 mutation and at least one affected first-degree relative with pancreatic cancer Screening is usually initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer; or per updated national screening guidelines 2. Lynch syndrome or Ataxia Telangiectasia Mutated (ATM) mutations with at least one affected first-degree relative (FDR). Lynch syndrome could be diagnosed either by using clinical criteria or Mutator L homolog 1 (MLH1), Mutator S homolog 2 (MSH2), Mutator S homolog 6 (MSH6), Postmeiotic Segregation Increased, S. Cerevisiae, 2 (PMS2) or EPCAM mutation. 3. Patients with hereditary pancreatitis diagnosed using clinical criteria or deleterious Serine Protease 1 (PRSS1) mutation. Screening is usually initiated at age 40 years or 10 years younger than the youngest family member with pancreatic cancer 3. New-onset diabetes, age \> 50 years with weight loss. 4. Patients who do not meet these CAPS screening criteria but are determined by the site principal investigator to be high-risk for pancreatic cancer based upon family history or other risk factors, and are undergoing pancreatic cancer screening will also be included in the study. Indication for pancreatic cancer screening and age at which screening was initiated will be recorded.	* Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging

Inclusion Criteria

Exclusion Criteria

* Inclusion criteria 1-3 are indications for pancreatic cancer screening as defined by the CAPS3 guidelines or updated national pancreatic cancer screening guidelines. Patients who do not meet these guidelines but are undergoing pancreatic cancer screening at the discretion of their treating physician at participating study centers will also be included in the study. Based upon the indication for screening, patients will be categorized as either meeting CAPS3 screening criteria, or not meeting CAPS3 screening criteria.
1. Familial Pancreatic cancer kindred. This is defined as family history of pancreas cancer that meet the criteria listed below.
1. If at least two affected relatives who are First degree relatives (FDR) to each other, of whom at least one is an FDR to the individual considered for surveillance
2. If at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance
3. If at least two affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance Screening is usually initialed at age 50 years or 10 years younger than the youngest family member with pancreatic cancer
2. Patients with genetic susceptibility to pancreas cancer
1. Patients with Peutz-Jeghers syndrome diagnosed with using clinical criteria or with a deleterious mutation in liver kinase B1/Serine/threonine kinase 11 (LKB1/STK11). Screening is usually initiated at age 40 years or later.
2. Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM syndrome), diagnosed using clinical criteria or CDKN2A p16 mutation.
1. Hereditary Breast and Ovarian Cancer syndrome: diagnosed using clinical criteria or deleterious Breast Cancer gene 1 (BRCA1), Breast Cancer gene 2 (BRCA2), Partner and Localizer of BRCA2 (PALB2). The usual indication for screening is:
* BRCA1 mutation and at least one affected first-degree relative with pancreatic cancer
* BRCA 2 mutation and at least one affected first-degree relative, or at least two relatives of any degree with pancreatic cancer
* PALB2 mutation and at least one affected first-degree relative with pancreatic cancer Screening is usually initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer; or per updated national screening guidelines
2. Lynch syndrome or Ataxia Telangiectasia Mutated (ATM) mutations with at least one affected first-degree relative (FDR). Lynch syndrome could be diagnosed either by using clinical criteria or Mutator L homolog 1 (MLH1), Mutator S homolog 2 (MSH2), Mutator S homolog 6 (MSH6), Postmeiotic Segregation Increased, S. Cerevisiae, 2 (PMS2) or EPCAM mutation.
3. Patients with hereditary pancreatitis diagnosed using clinical criteria or deleterious Serine Protease 1 (PRSS1) mutation. Screening is usually initiated at age 40 years or 10 years younger than the youngest family member with pancreatic cancer 3. New-onset diabetes, age \> 50 years with weight loss. 4. Patients who do not meet these CAPS screening criteria but are determined by the site principal investigator to be high-risk for pancreatic cancer based upon family history or other risk factors, and are undergoing pancreatic cancer screening will also be included in the study. Indication for pancreatic cancer screening and age at which screening was initiated will be recorded.

* Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging

Contacts and Locations

Study Contact

Roya Dastjerdi, MD

CONTACT

617-667-4046

rdastjer@bidmc.harvard.edu

Principal Investigator

Mandeep Sawhney, MD,MS,FASGE

PRINCIPAL_INVESTIGATOR

BIDMC-Harvard Medical School

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Mandeep Sawhney, MD,MS,FASGE, PRINCIPAL_INVESTIGATOR, BIDMC-Harvard Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-10

Study Completion Date2032-12-31

Study Record Updates

Study Start Date2020-07-10

Study Completion Date2032-12-31

Terms related to this study

Keywords Provided by Researchers

Pancreatic cancer screening
Early detection of pancreatic cancer
Genetic susceptibility to pancreatic cancer
BRCA 1
BRCA 2
familial pancreatic cancer
Endoscopic Ultrasound
MRI

Additional Relevant MeSH Terms

Pancreatic Cancer, Adult