Pancreatic Cancer Screening for At-risk Individuals

NCT05006131 | Recruiting

• 1 other identifier: 2020P000872
• Study Type: observational
• Target: 1,395
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer, Adult

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatment

  Proportion of patients who meet CAPS 3 or updated national screening guidelines criteria who are found at screening to have high-risk pancreatic lesions amenable to treatment. These are defined as the following: 1. Lesions with high-grade dysplasia (HGD) 2. High-grade pancreatic intraepithelial neoplasia (PanIN) 3. Resectable or borderline resectable pancreatic cancer. Pancreatic cancers that were staged T1-3, N0-2, and M0 designated as resectable or borderline resectable. Cancers that were staged as T4 or M1 were considered locally advanced or metastatic and therefore designated as unresectable 4. Main duct intra-ductal papillary mucinous neoplasm (IPMN).This will be defined per Fukuoko guidelines as dilation of main pancreatic duct ≥ 5 mm, after duct dilation due to other causes have been excluded. 5. Branch-duct IPMN with "worrisome features". 6. Neuroendocrine tumor ≥ 2 cm.

  From year 1 to year 12 (until the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team.

Secondary Outcomes (6)

• Proportion of screening patients found to have high-risk pancreatic lesions

  From year 1 screening to year 12 (end of at least 5 years follow up in 2032) screening (annually)

• Proportion of screening patients found to have low or moderate-risk pancreatic lesions by screening

  From year 1 to year 12 (end of at least 5 years follow up in 2032) according to the standard of care designated by GI team.

• Proportion of patients undergoing screening who undergo pancreatic surgery

  From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)

• Proportion of "low yield" pancreatic surgeries performed in screening patients

  From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)

• Proportion of screening patients who undergo non-pancreatic surgery

  From year 1 to year 12 (the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team

Study Arms (1)

Patients who are at high-risk for pancreatic cancer

Patients that meet the eligibility criteria based on CAPS3 or updated national pancreatic cancer screening guidelines

Other: Screening for pancreatic cancer

Interventions

Screening for pancreatic cancer OTHER

Screening for pancreatic cancer using EUS or MRI

Patients who are at high-risk for pancreatic cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient who meets the eligibility criteria exposed above based on CAPS3 or updated national pancreatic screening guidelines criteria at BIDMC and collaboration centers part of the study in the time frame of 2020 to 2027 (which is the end of enrollment)

You may qualify if:

• Familial Pancreatic cancer kindred. This is defined as family history of pancreas cancer that meet the criteria listed below.
• 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
• 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
• 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
• Patients with genetic susceptibility to pancreas cancer
• 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.
• 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.
• 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
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: collaborator
• Beth Israel Deaconess Medical Center: lead
• Washington University School of Medicine: collaborator
• Zucker School of Medicine at Hofstra/Northwell: collaborator
• Rush University Medical Center: collaborator
• Wake Forest University: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (13)

• Borgida, A., Holter, S., Thomas, C., Jhaveri, K., Haider, M. A., & Gallinger, S. Screening individuals at increased risk for pancreatic cancer using biannual contrast MRI. Familial Cancer, 2017, 16 (1 Supplement 1), S108

  BACKGROUND

• Canto MI, Almario JA, Schulick RD, Yeo CJ, Klein A, Blackford A, Shin EJ, Sanyal A, Yenokyan G, Lennon AM, Kamel IR, Fishman EK, Wolfgang C, Weiss M, Hruban RH, Goggins M. Risk of Neoplastic Progression in Individuals at High Risk for Pancreatic Cancer Undergoing Long-term Surveillance. Gastroenterology. 2018 Sep;155(3):740-751.e2. doi: 10.1053/j.gastro.2018.05.035. Epub 2018 May 24.

  PMID: 29803839 BACKGROUND

• Corral JE, Mareth KF, Riegert-Johnson DL, Das A, Wallace MB. Diagnostic Yield From Screening Asymptomatic Individuals at High Risk for Pancreatic Cancer: A Meta-analysis of Cohort Studies. Clin Gastroenterol Hepatol. 2019 Jan;17(1):41-53. doi: 10.1016/j.cgh.2018.04.065. Epub 2018 Jun 30.

  PMID: 29775792 BACKGROUND

• Gangi A, Malafa M, Klapman J. Endoscopic Ultrasound-Based Pancreatic Cancer Screening of High-Risk Individuals: A Prospective Observational Trial. Pancreas. 2018 May/Jun;47(5):586-591. doi: 10.1097/MPA.0000000000001038.

  PMID: 29683970 BACKGROUND

• Goggins M, Overbeek KA, Brand R, Syngal S, Del Chiaro M, Bartsch DK, Bassi C, Carrato A, Farrell J, Fishman EK, Fockens P, Gress TM, van Hooft JE, Hruban RH, Kastrinos F, Klein A, Lennon AM, Lucas A, Park W, Rustgi A, Simeone D, Stoffel E, Vasen HFA, Cahen DL, Canto MI, Bruno M; International Cancer of the Pancreas Screening (CAPS) consortium. Management of patients with increased risk for familial pancreatic cancer: updated recommendations from the International Cancer of the Pancreas Screening (CAPS) Consortium. Gut. 2020 Jan;69(1):7-17. doi: 10.1136/gutjnl-2019-319352. Epub 2019 Oct 31.

  PMID: 31672839 BACKGROUND

• Kogekar N, Diaz KE, Weinberg AD, Lucas AL. Surveillance of high-risk individuals for pancreatic cancer with EUS and MRI: A meta-analysis. Pancreatology. 2020 Dec;20(8):1739-1746. doi: 10.1016/j.pan.2020.10.025. Epub 2020 Oct 9.

  PMID: 33077384 BACKGROUND

• Kwon, R., Dust, H., McCarthy, S., Hosmer, A., Carulli, A., Scheiman, J., . . . Stoffel, E Outcomes of pancreatic cancer surveillance in high risk individuals. American Journal of Gastroenterology, 2019, 114 (Supplement), S19.

  BACKGROUND

• Lachter J, Rosenberg C, Hananiya T, Khamaysi I, Klein A, Yassin K, Half E. Screening to Detect Precursor Lesions of Pancreatic Adenocarcinoma in High-risk Individuals: A Single-center Experience. Rambam Maimonides Med J. 2018 Oct 4;9(4):e0029. doi: 10.5041/RMMJ.10353.

  PMID: 30309438 BACKGROUND

• Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.

  PMID: 24840647 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

  PMID: 31912902 BACKGROUND

• Tanaka M, Fernandez-Del Castillo C, Kamisawa T, Jang JY, Levy P, Ohtsuka T, Salvia R, Shimizu Y, Tada M, Wolfgang CL. Revisions of international consensus Fukuoka guidelines for the management of IPMN of the pancreas. Pancreatology. 2017 Sep-Oct;17(5):738-753. doi: 10.1016/j.pan.2017.07.007. Epub 2017 Jul 13.

  PMID: 28735806 BACKGROUND

• van Roessel S, Kasumova GG, Verheij J, Najarian RM, Maggino L, de Pastena M, Malleo G, Marchegiani G, Salvia R, Ng SC, de Geus SW, Lof S, Giovinazzo F, van Dam JL, Kent TS, Busch OR, van Eijck CH, Koerkamp BG, Abu Hilal M, Bassi C, Tseng JF, Besselink MG. International Validation of the Eighth Edition of the American Joint Committee on Cancer (AJCC) TNM Staging System in Patients With Resected Pancreatic Cancer. JAMA Surg. 2018 Dec 1;153(12):e183617. doi: 10.1001/jamasurg.2018.3617. Epub 2018 Dec 19.

  PMID: 30285076 BACKGROUND

• Shah I, Silva-Santisteban A, Germansky KA, Trindade A, Raphael KL, Kushnir V, Pawa R, Mishra G, Anastasiou J, Inamdar S, Tharian B, Bilal M, Sawhney MS. Pancreatic Cancer Screening for At-Risk Individuals (Pancreas Scan Study): Yield, Harms, and Outcomes From a Prospective Multicenter Study. Am J Gastroenterol. 2023 Sep 1;118(9):1664-1670. doi: 10.14309/ajg.0000000000002314. Epub 2023 May 4.

  PMID: 37141538 DERIVED

MeSH Terms

Conditions

Pancreatic cancer, adult; Pancreatic carcinoma, familial

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Mandeep Sawhney, MD,MS,FASGE

  BIDMC-Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roya Dastjerdi, MPH

CONTACT

617-667-4046; rdastjer@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director for GI Endoscopy & Director for Endoscopy Research, BIDMC

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 16, 2021
• Study Start: July 10, 2020
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)