Pancreatic Ductal AdenocarcinomaNCT02790944
Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer
An observational study of Pancreatic Ductal Adenocarcinoma, run by Ambry Genetics at 3 sites in United States.
Trial summary
The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Multi-gene Next Generation Sequencing Panel
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 May 2016to 15 Aug 2020
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be patients who are diagnosed within 12 weeks of enrollment with Pancreatic Ductal Adenocarcinoma.
Who may be able to join
- Male and female patients between the ages of 18 and 89 years of age.
- Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
Who cannot join
- Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
- Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
- Patients meeting the above enrollment criteria who have had CancerNext performed previously.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5400
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer in Consecutive Cases Unselected for Family History
The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.
Read the detailed description
The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Multi-gene Next Generation Sequencing Panel
- Keywords
- Germline, Pancreatic, Genetic Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-gene Next Generation Sequencing PanelGenetic
Also called CancerNext
Participants will have genetic testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Germline Mutation Prevalence
The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively to the clinical site within 12 weeks of a histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
Measured: 18 months
Secondary outcomes (2)
Associate age at diagnosis with germline mutation status and family history
Measured: 18 months
Access the psychological impact of testing for hereditary pancreatic cancer
A previously validated questionnaire, the Multidimensional Impact of Cancer Risk Assessment (MICRA) will be used as a measure of the psychological impact of genetic testing.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start4 May 2016
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambry Genetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, HonorHealth Research Institute
- Responsible party
- Sponsor
- Investigators
- Randall Brand, MD, Principal investigator, University of PittsburghNadine Tung, MD, Principal investigator, Beth Israel DeaconessErkut Borazanci, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790944
- Sponsor's protocol ID
- NEX_14_028
- Status last verified
- Jan 2020
- First submitted
- 25 May 2016
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cella D, Hughes C, Peterman A, Chang CH, Peshkin BN, Schwartz MD, Wenzel L, Lemke A, Marcus AC, Lerman C. A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychol. 2002 Nov;21(6):564-72.
PubMed 12433008
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer in Consecutive Cases Unselected for Family History
- ClinicalTrials.gov ID
- NCT02790944
- Acronym / sponsor ID
- NEX_14_028
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Germline, Pancreatic, Genetic Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ambry GeneticsIndustry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, HonorHealth Research Institute
- Study start
- 4 May 2016 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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.
The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.
Detailed description
The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients who are diagnosed within 12 weeks of enrollment with Pancreatic Ductal Adenocarcinoma.
Key inclusion criteria (4 listed)
- Male and female patients between the ages of 18 and 89 years of age.
- Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
Key exclusion criteria (3 listed)
- Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
- Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
- Patients meeting the above enrollment criteria who have had CancerNext performed previously.
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 |
|---|---|---|
| Multi-gene Next Generation Sequencing PanelAlso: CancerNextParticipants will have genetic testing | Genetic | – |
Primary outcome
Germline Mutation Prevalence
Time frame: 18 months
The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively to the clinical site within 12 weeks of a histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
2 secondary outcomes
Associate age at diagnosis with germline mutation status and family history
Time frame: 18 months
Access the psychological impact of testing for hereditary pancreatic cancer
Time frame: 18 months
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 25 Aug 2020.
- Background: PubMed 12433008Cella D, Hughes C, Peterman A, Chang CH, Peshkin BN, Schwartz MD, Wenzel L, Lemke A, Marcus AC, Lerman C. A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychol. 2002 Nov;21(6):564-72.
- Individual participant dataSharing planned: Undecided
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Pancreatic Ductal Adenocarcinoma (PDAC)
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.
Randall Brand, MD principal investigator
University of Pittsburgh
Nadine Tung, MD principal investigator
Beth Israel Deaconess
Erkut Borazanci, MD principal investigator
HonorHealth Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Ambry Genetics at 3 sites 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 4 inclusion and 3 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Germline Mutation Prevalence (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790944, which also lists 1 linked publication.
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 25 Aug 2020.