Clinical trial NCT05380557: ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
Official title: ARTEMIS: A Prospective Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Adenocarcinoma
Pancreatic Cancer
Resectable Pancreatic Cancer
Keywords: germline genetic testing
oncology
pancreatic cancer
resectable pancreatic cancer
early stage pancreatic cancer
Lead sponsor: Invitae Corporation
Sponsor class: INDUSTRY
Collaborators: name: Eastern Cooperative Oncology Group
First posted: 2022-05-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with resectable pancreatic cancer.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel
timeFrame: Will be assessed at baseline only.
measure: Overall survival
timeFrame: Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing
measure: Overall survival
timeFrame: Will be assessed every 6 months for years 2 - 10 post germline testing
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Invitae SF
state: California
Study officials:
References: