Pancreatic Cancer Early Detection Registry

NCT05519930 | Completed

• 1 other identifier: 113-16-CA
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Hereditary High Risk

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

hereditary high risk pancreatic cancer OTHER

Data collection trial for hereditary high risk pancreatic cancer patients.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Eligible subjects must be ≥ 18 years of age
• 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)
• 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:
• relative with ovarian cancer at any age or
• relative with breast cancer ≤50 or
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Valentina Dalili-Shoaie, MD

  Hoag Memorial Hospital Presbyterian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 99 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 29, 2022
• Study Start: October 18, 2016
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)