Pancreatic Cancer Screening for At-risk Individuals

Pancreatic Cancer, Adult Clinical Trial

— PancreasScan  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006131
• Other study ID #: 2020P000872
• Status: Recruiting
• Start date: July 10, 2020
• Est. completion date: March 10, 2028

Study information

• Verified date: March 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Roya Dastjerdi, MD
• Phone: 617-667-4046
• Email: rdastjer[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Methods The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of pancreas cancer screening in high-risk individuals. High-risk patients who are undergoing pancreatic cancer screening in accordance with national guidelines at participating study centers will be eligible for the study. Information regarding patient characteristics, findings at screening examination, and patient outcomes will be collected.

Primary Outcome (Primary Aim):

To identify the proportion of patients who meet International Cancer of the Pancreas Screening Consortium screening criteria 3rd update (CAPS Jan 2020), or more updated national guidelines, who are found at the screening to have high-risk pancreatic lesions amenable to treatment (definition of "high-risk lesions amenable to treatment" is provided under the section on study outcomes).

Secondary outcomes (Secondary Aims) will include (details are provided under the section on study outcomes):

1. Proportion of patients diagnosed with any stage pancreatic cancer

2. proportion of patients undergoing pancreatic surgery

3. Cancer-related outcome, defined as a cancer-related death

4. proportion of patients experience harms, defined as any complications/adverse event due to screen related procedures

5. Comparison of cancer outcome, defined cancer-related death, in screen-detected cancer with cancer outcomes reported by the SEERs population-based registry. Study overview Study type: a prospective observational cohort High-risk patients who meet study inclusion criteria at study centers will be identified.

Screening and patient follow-up will be performed at individual study centers per standard clinical practice. Patient characteristics, screening performed and screening results, clinical outcome data will be collected by individual study centers. This data will be stored and analyzed at central study REDCap located at Beth Israel Deaconess Medical Center (BIDMC)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 10, 2028
• Est. primary completion date: March 10, 2027
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer, Adult
• Pancreatic Neoplasms

Intervention

Other:
• Screening for pancreatic cancer
Screening for pancreatic cancer using EUS or MRI

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Central Arkansas Veterans Healthcare System, Rush University Medical Center, University of Arkansas, W.G. Bill Hefner Medical Center, Wake Forest University Health Sciences, Washington University School of Medicine, Zucker School of Medicine at Hofstra/Northwell

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Gut. 2020 Jun;69(6):e3. — View Citation

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. — View Citation

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.

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. — View Citation

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. Erratum In: Cancer Res. 2014 Jul 15;74(14):4006. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA Surg. 2019 Feb 20;: — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Lesions with high-grade dysplasia (HGD), High-grade pancreatic intraepithelial neoplasia (PanIN), 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, Main duct intra-ductal papillary mucinous neoplasm (IPMN)., Branch-duct IPMN with "worrisome features", cyst associated with an abrupt change in main pancreatic duct caliber with pancreatic atrophy, Neuroendocrine tumor = 2 cm.	From year 1 to year 8, according to the standard of care designated by GI team.
Secondary	Proportion of screening patients found to have high-risk pancreatic lesions	Proportion of patients who meet CAPS screening eligibility criteria, who are found at screening to have high-risk pancreatic lesions amenable to treatment	From year 1 screening to year 8 screening (annually)
Secondary	Proportion of screening patients found to have low or moderate-risk pancreatic lesions by screening	Proportion of patients undergoing pancreatic cancer screening who are found to have low or moderate-risk pancreatic lesions. Low or moderate-risk pancreatic lesions pancreatic lesions are defined as: Branch-duct IPMN without HGD; Neuroendocrine tumor < 2 cm; dilation of main pancreatic duct < 8 mm; Chronic pancreatitis-like change	From year 1 to year 8, according to the standard of care designated by GI team.
Secondary	Proportion of patients undergoing screening who undergo pancreatic surgery	Proportion of patients who undergo pancreatic surgery as a result of screening test results following the Fukuoka revised guidelines for the management for high-risk lesions or surgical treatment designated by interdisciplinary medical team	From year 1 to year 8.(throughout the duration of the study)
Secondary	Proportion of "low yield" pancreatic surgeries performed in screening patients	Proportion of patients who undergo "low-yield pancreatic surgery" as a result of screening test results. Low yield pancreatic surgery is defined surgery where surgical pathology does not yield high-risk pancreatic lesions. See primary outcome for definition of high-risk pancreatic lesions.	From year 1 to year 8.(throughout the duration of the study)
Secondary	Proportion of screening patients who undergo non-pancreatic surgery	Proportion of patients who undergo non- pancreatic surgery as a result of screening test results.	From year 1 to year 8, according to the standard of care designated by GI team
Secondary	Proportion of screening patients who experience complications/adverse events of screen-related procedures	Proportion of patients who experienced any complications or adverse events due to screen-related procedures as Endoscopic Ultrasound (EUS), Magnetic resonance cholangiopancreatography (MRCP) or others that have been designated by attending in the GI department. Complications and adverse events will be aggregated to be reported as one value (complications/adverse events). Complications, defined as adverse events that emphasize direct causality between medical care and the adverse outcome or event. Adverse event, defined as an event that may or may not be preventable or result from a medical error	From year 1 to year 8, according to standard of care designated by GI team