Clinical trial NCT05519930: Pancreatic Cancer Early Detection Registry
Official title: Pancreatic Cancer Early Detection Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Hereditary High Risk
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Eight years
measure: 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.
timeFrame: Eight years
measure: 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
timeFrame: Eight years
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Hoag Memorial Hospital Presbyterian
name: Valentina Dalili-Shoaie, MD
role: PRINCIPAL_INVESTIGATOR
References: