Pancreatic CancerNCT03060720
Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
An observational study of Pancreatic Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient seen at Dana Farber Cancer Institute with a diagnosis of pancreatic ductal adenocarcinoma
Who may be able to join
- Diagnosis of pancreatic ductal adenocarcinoma
- Signed initial informed consent
- Participant agrees to genetic counseling
Who cannot join
- Prospective participant unable to sign informed consent based on referring physician recommendation.
- Patient has neuroendocrine pancreatic tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations
Read the detailed description
This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.
The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.
The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool
Measured: Up to 5 years
Secondary outcomes (3)
Evaluate Patient Experience With Genetic Testing
Measured: up to 5 years
Summarize patient satisfaction with Genetic counseling
Measured: up to 5 years
Number of patients who disclose genetic testing results to relatives
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start24 Feb 2017
- Primary completion7 Apr 2019
- Study completionFeb 2028 (estimated)
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.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Matthew B. Yurgelun, MD, Dana-Farber Cancer Institute
- Investigators
- Matthew B Yurgelun, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060720
- Sponsor's protocol ID
- 16-448
- Other IDs
- P50CA127003
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2017
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
- ClinicalTrials.gov ID
- NCT03060720
- Acronym / sponsor ID
- 16-448
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 7 Apr 2019 (actual)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Feb 2017 (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.
This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations
Detailed description
This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.
The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.
The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient seen at Dana Farber Cancer Institute with a diagnosis of pancreatic ductal adenocarcinoma
Key inclusion criteria (3 listed)
- Diagnosis of pancreatic ductal adenocarcinoma
- Signed initial informed consent
- Participant agrees to genetic counseling
Key exclusion criteria (2 listed)
- Prospective participant unable to sign informed consent based on referring physician recommendation.
- Patient has neuroendocrine pancreatic tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool
Time frame: Up to 5 years
3 secondary outcomes
Evaluate Patient Experience With Genetic Testing
Time frame: up to 5 years
Summarize patient satisfaction with Genetic counseling
Time frame: up to 5 years
Number of patients who disclose genetic testing results to relatives
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- 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.
Matthew B Yurgelun, MD principal investigator
Dana-Farber Cancer Institute
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 Dana-Farber Cancer Institute 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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool (time frame: Up to 5 years). 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 30 Mar 2026.