Pancreatic AdenocarcinomaARTEMISNCT05380557
ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
An observational study of Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Invitae Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Pancreatic Cancer, Resectable Pancreatic Cancer
- What is being tested?
- Germline genetic testing
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 6 Sep 2022
- 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: Adults with resectable pancreatic cancer.
Who may be able to join
- 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
Who cannot join
- Patient has evidence of metastatic or recurrent pancreatic cancer at time of consent
- Patient is unable to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Germline genetic testing
- Keywords
- germline genetic testing, oncology, pancreatic cancer, resectable pancreatic cancer, early stage pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Germline genetic testingDiagnostic test
Germline genetic testing will be provided to each patient
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Germline genetic testing | |
| 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. Receives: Diagnostic Test: Germline genetic testing | |
| 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. Receives: Diagnostic Test: Germline genetic testing | |
| 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. Receives: Diagnostic Test: Germline genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel
Measured: Will be assessed at baseline only.
Overall survival
Measured: Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing
Overall survival
Measured: Will be assessed every 6 months for years 2 - 10 post germline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start23 Aug 2021
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Why it stopped: Low site engagement and accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invitae Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eastern Cooperative Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380557
- Sponsor's protocol ID
- CR-001-15
- Acronym
- ARTEMIS
- Status last verified
- Dec 2022
- First submitted
- 1 Apr 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTEMIS: A Prospective Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
- ClinicalTrials.gov ID
- NCT05380557
- Acronym / sponsor ID
- ARTEMIS / CR-001-15
- Keywords
- germline genetic testing, oncology, pancreatic cancer, resectable pancreatic cancer, early stage pancreatic cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low site engagement and accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Invitae CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Eastern Cooperative Oncology Group
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 19 May 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Germline Pathogenic Variant in non-BRCA/PALB2 Gene | – | Diagnostic Test: Germline genetic testingPatients 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. |
| Strong family history of pancreatic cancer but no identifiable germline pathogenic variant | – | Diagnostic Test: Germline genetic testingPatients 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. |
| Negative germline testing and absence of strong family history | – | Diagnostic Test: Germline genetic testingPatients 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. |
| Pathogenic Variant in BRCA1/2 or PALB2 | – | Diagnostic Test: Germline genetic testingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with resectable pancreatic cancer.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Patient has evidence of metastatic or recurrent pancreatic cancer at time of consent
- Patient is unable to consent.
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 |
|---|---|---|
| Germline genetic testingGermline genetic testing will be provided to each patient | Diagnostic test | Germline Pathogenic Variant in non-BRCA/PALB2 Gene, Negative germline testing and absence of strong family history, Pathogenic Variant in BRCA1/2 or PALB2, Strong family history of pancreatic cancer but no identifiable germline pathogenic variant |
Primary outcome
Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel
Time frame: Will be assessed at baseline only.
Overall survival
Time frame: Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing
Overall survival
Time frame: Will be assessed every 6 months for years 2 - 10 post germline testing
Results and safety
The study was stopped early (reason given: Low site engagement and accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adenocarcinoma and Pancreatic Cancer, run by Invitae Corporation 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 6 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: stopped early, as of the sponsor's last update on 7 Dec 2022. 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 was stopped early (reason given: Low site engagement and accrual). Results are not available in the source record.
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 pathogenic variants identified on Invitae's 84 gene Multi Cancer panel (time frame: Will be assessed at baseline only.). 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 7 Dec 2022.