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Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer

Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01662609
Enrollment
90
Registered
2012-08-10
Start date
2007-08-23
Completion date
2022-08-16
Last updated
2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

pancreas, high-risk

Brief summary

The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.

Interventions

Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer * If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened * If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened * Patients at least 40 years old or 10 years younger than the youngest affected individual * Peutz-Jeghers Syndrome (PJS) patients age\>30 * Hereditary pancreatitis patients * Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM) * Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer * Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA) * Willingness to undergo surgical evaluation for abnormal EUS/FNA finding * Willingness to undergo radiographic evaluation if screening findings are abnormal

Exclusion criteria

* Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope * Personal history of pancreatic adenocarcinoma * Previous partial or complete resection of the pancreas for adenocarcinoma * Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis * Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years * Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV) * Life expectancy less than 5 years * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Number of Abnormalities Detected by EUSAverage of 5 yearsTo determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026