Screening for pancreatic cancer in high-risk individuals
Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)
This study is testing if screening for pancreatic cancer helps high-risk individuals catch the disease early and improve their chances of successful treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1395 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05006131 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of pancreatic cancer screening in individuals identified as high-risk according to established guidelines. It will be a prospective multicenter observational study that collects data on patient characteristics, screening findings, and outcomes. Participants will be screened for pancreatic cancer based on the International Cancer of the Pancreas Screening Consortium recommendations, and the study will assess the proportion of patients diagnosed with high-risk lesions and pancreatic cancer. Secondary outcomes will include surgical interventions and cancer-related mortality.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a familial history of pancreatic cancer or those meeting specific genetic risk criteria.
Not a fit: Patients without a significant family history of pancreatic cancer or those who do not meet the screening criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and treatment of pancreatic cancer in at-risk individuals, potentially improving survival rates.
How similar studies have performed: Other studies have shown promise in early detection of pancreatic cancer through screening in high-risk populations, supporting the feasibility of this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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.
Screening is usually initiated at age 45 years or 10 years younger than the youngest family member with pancreatic cancer.
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.
Screening to be initiated at age 45 or 10 years younger than the youngest family member with pancreatic cancer.
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.
Exclusion Criteria:
* Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mandeep Sawhney, MD,MS,FASGE — BIDMC-Harvard Medical School
- Study coordinator: Roya Dastjerdi, MPH
- Email: rdastjer@bidmc.harvard.edu
- Phone: 617-667-4046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.