CompletedNCT02790944Updated Aug 25, 2020

Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

An observational study in Pancreatic Ductal Adenocarcinoma, sponsored by Ambry Genetics. Completed at 3 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2020-08-25.

Sponsored by Ambry Genetics · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 300
Ages: 18 Years to 89 Years
Sex: All

Study 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 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 studied

Pancreatic Ductal Adenocarcinoma

Keywords

Germline
Pancreatic
Genetic Testing

In context

Lead sponsor

Ambry Genetics is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 89 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

The study population will be patients who are diagnosed within 12 weeks of enrollment with Pancreatic Ductal Adenocarcinoma.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 300 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Interventions

GeneticMulti-gene Next Generation Sequencing Panel
Participants will have genetic testing
Also known as: CancerNext

What researchers measure

Primary outcomes

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.
Time frame: 18 months

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
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.
Time frame: 18 months

Study locations

3 sites

HonorHealth Research Institute
Scottsdale, Arizona 85258, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215-5400, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232, United States

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02790944
Lead sponsor: Ambry Genetics
Collaborators: Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, HonorHealth Research Institute
Responsible party: Sponsor
First posted: Jun 6, 2016
Start date: May 4, 2016
Primary completion: Aug 15, 2020
Completion: Aug 15, 2020
Last update: Aug 25, 2020

Study contacts

Randall Brand, MD

principal investigator · University of Pittsburgh

Nadine Tung, MD

principal investigator · Beth Israel Deaconess

Erkut Borazanci, MD

principal investigator · HonorHealth Research Institute

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Ambry Genetics

Start the discussion