Pancreatic CancerNCT05519930
Pancreatic Cancer Early Detection Registry
An observational study of Pancreatic Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- hereditary high risk pancreatic cancer
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2016to 27 Jul 2023
- How long will I take part?
- 99 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
- 1 FDR with pancreatic cancer < age 55
Show all 16Show fewer
- -≥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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
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.
Read the 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
- Being tested
- hereditary high risk pancreatic cancer
- Keywords
- Pancreatic Cancer, Hereditary High Risk
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hereditary high risk pancreatic cancerOther
Data collection trial for hereditary high risk pancreatic cancer patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Eight years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start18 Oct 2016
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
- Target duration
- 99 Years
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina Dalili-Shoaie, MD, Principal investigator, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519930
- Sponsor's protocol ID
- 113-16-CA
- Status last verified
- Oct 2024
- First submitted
- 22 Aug 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Early Detection Registry
- ClinicalTrials.gov ID
- NCT05519930
- Acronym / sponsor ID
- 113-16-CA
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Hereditary High Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 99 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- Eligible subjects must be ≥ 18 years of age
- Meet one of the following criteria:
- -≥2 FDR, SDR or TDR with pancreatic cancer at any age
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hereditary high risk pancreatic cancerData collection trial for hereditary high risk pancreatic cancer patients. | Other | – |
Primary outcome
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.
Time frame: Eight years
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.
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.
Time frame: 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
Time frame: Eight years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Dalili-Shoaie, MD principal investigator
Hoag Memorial Hospital Presbyterian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Eight years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.