Pancreatic Cancer Early Detection Registry

Pancreatic Cancer Clinical Trial

Official title:

Pancreatic Cancer Early Detection Registry

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05519930
• Other study ID #: 113-16-CA
• Status: Suspended
• Start date: October 18, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: Hoag Memorial Hospital Presbyterian
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Identify individuals who are at moderate and high risk or predisposed to developing pancreatic cancer with a familial history in which data collected from this study will be used to identify clinical factors associated with early detection of pancreatic cancer.

Description:

Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. In 2015, there were 49,000 new diagnoses with 41,000 deaths . A recent analysis of the pedigrees in the National Familial Pancreatic Tumor Registry found that individuals with a family history of pancreatic cancer in first-degree relatives are at an increased risk of developing pancreatic cancer themselves. There are more than a dozen inherited germline mutations that increase the risk of pancreatic cancer in these family members. In an attempt to lower the number of individuals that develop advanced pancreatic cancer, an early-detection program is created to detect tumors at a stage early enough that treatment is likely to be successful. Numerous treatment options exist such as surveillance, radiation therapy, systemic therapy and surgery. Determining which treatment option will be implemented is based on the stage and grade of the tumor/cancer.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Eligible subjects must be = 18 years of age

2. Meet one of the following criteria:

• All affected on the same side of the family (maternal/paternal) unless otherwise specified FDR = first degree relative (parent, sibling, child)

• SDR = second degree relative (e.g., aunt, uncle, grandparent, half-sibling, niece and nephew)

• TDR = third degree relative (e.g., cousin, half-aunt or half-uncle)

• 1 FDR with pancreatic cancer < age 55

-=2 FDR, SDR or TDR with pancreatic cancer at any age

• Genetic syndrome with pancreatic cancer

• FDR or SDR with pancreatic cancer at any age and Ashkenazi ancestry

• FDR or SDR with pancreatic cancer at any age and:

• 1 relative with ovarian cancer at any age or

• 1 relative with breast cancer =50 or

• 2 relatives with breast, pancreatic or prostate cancer (Gleason score =7) at any age

• Family history of melanoma OR

• Has previously had genetic testing and has been determined to have a pathogenic gene variant.

• FDR with a pathogenic gene variant

Exclusion Criteria:

1. Prior treatment of pancreatic cancer including radiation therapy, systemic therapy and/or surgery.

2. Current treatment of pancreatic cancer including radiation therapy, systemic therapy and/or surgery.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• hereditary high risk pancreatic cancer
Data collection trial for hereditary high risk pancreatic cancer patients.

Locations

Country	Name	City	State
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of imaging for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly.	Imaging includes CT/MRI abdomen with and without contrast using the pancreatic protocol, screening for solid pancreatic lesions, atypical cysts and IPMN, pancreatic duct dilatation, pancreas divisum.	Eight years
Primary	Evaluation of blood samples for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly.		Eight years
Primary	Evaluation of endoscopic ultrasound for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly		Eight years