Pancreatic Cancer Early Detection Registry

NCT ID: NCT05519930

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-18
• Study Completion Date: 2023-07-27

Brief 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.

Detailed 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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

hereditary high risk pancreatic cancer

Data collection trial for hereditary high risk pancreatic cancer patients.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentina Dalili-Shoaie, MD

Role: PRINCIPAL_INVESTIGATOR

Hoag Memorial Hospital Presbyterian

Locations

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Countries

United States

Other Identifiers

113-16-CA

Identifier Type: -

Identifier Source: org_study_id