- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05380557
ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing (ARTEMIS)
ARTEMIS: A Prospective Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
This study includes participants with pancreatic cancer who are undergoing genetic testing at Invitae related to their diagnosis of pancreatic cancer.
Our goal in this study is two-fold. First, we would like to research whether any inherited changes in genes may be associated with pancreatic cancer. Second, we would like to learn more about patient experiences with genetic testing, such as patient understanding of the testing, health-related actions taken (or planned to take) as a result of testing, communication and action of family members based on test results, and psychological impact of testing.
This research study involves allowing collection of tumor tissue (from a prior biopsy and/or surgery), a blood sample, and sending surveys to participants for their opinion on the impact of the genetic testing as well as clinicians for relevant baseline and medical history information.
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients will be contacted for patient outcomes survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, and 60. Patients will also be contacted for survival collection every 6 months during years 3-5 post germline testing.
Clinicians will be contacted for relevant medical history, treatment, and survival data at the same time points.
At baseline, 3 samples types will be collected: 1. EDTA tube for germline genetic testing. 2. Streck tubes for whole genome sequencing and other analyses. 3. Tumor block from surgical resection. If block is unavailable 10 unstained slides are an acceptable substitute.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94103
- Invitae SF
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient has consented to germline genetic testing
- Patient has a histologically confirmed diagnosis of pancreatic cancer
- Patient has undergone or is planned to undergo surgical resection with curative intent
- Patient is willing to allow collection of a tissue sample from surgical resection
- Patient is willing to provide research blood samples (every 6 months for 2 years)
- Patient must be at least 18 years of age
Exclusion Criteria:
- Patient has evidence of metastatic or recurrent pancreatic cancer at time of consent
- Patient is unable to consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Germline Pathogenic Variant in non-BRCA/PALB2 Gene
Patients will receive germline testing and provide streck tube blood samples and archival tissue sample at baseline.
After germline testing results have been generated and released, patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-10 post germline testing.
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Germline genetic testing will be provided to each patient
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Strong family history of pancreatic cancer but no identifiable germline pathogenic variant
Patients will receive germline testing and provide streck tube blood samples and archival tissue sample at baseline.
After germline testing results have been generated and released, patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-10 post germline testing.
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Germline genetic testing will be provided to each patient
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Negative germline testing and absence of strong family history
Patients will receive germline testing and provide streck tube blood samples and archival tissue sample at baseline.
After germline testing results have been generated and released, patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-10 post germline testing.
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Germline genetic testing will be provided to each patient
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Pathogenic Variant in BRCA1/2 or PALB2
Patients will be offered enrollment into the sister trial, APOLLO (NCT04858334).
Patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-5.
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Germline genetic testing will be provided to each patient
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel
Time Frame: Will be assessed at baseline only.
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Will be assessed at baseline only.
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Overall survival
Time Frame: Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing
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Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing
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Overall survival
Time Frame: Will be assessed every 6 months for years 2 - 10 post germline testing
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Will be assessed every 6 months for years 2 - 10 post germline testing
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-001-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Invitae may share de-identified information and data generated through the study with third parties, including biopharmaceutical companies and biomedical researchers (e.g. academic), for clinical trials, drug development, and other disease-related research purposes.
Only a subset of Invitae personnel will have access to PHI. The PHI will be stored in a secure location and will only be made available to Invitae personnel involved in the Study. Any academic publication of data analysis from this Study will use de-identified information only.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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