ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing

NCT05380557 | Terminated

• 1 other identifier: CR-001-15
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma; Pancreatic Cancer; Resectable Pancreatic Cancer

Keywords

germline genetic testing; oncology; pancreatic cancer; resectable pancreatic cancer; early stage pancreatic cancer

Outcome Measures

Primary Outcomes (3)

• Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel

  Will be assessed at baseline only.

• Overall survival

  Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing

• Overall survival

  Will be assessed every 6 months for years 2 - 10 post germline testing

Study Arms (4)

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.

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.

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.

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.

Diagnostic Test: Germline genetic testing

Interventions

Germline genetic testing DIAGNOSTIC_TEST

Germline genetic testing will be provided to each patient

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with resectable pancreatic cancer.

You may qualify if:

• 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

You may not qualify if:

• Patient has evidence of metastatic or recurrent pancreatic cancer at time of consent
• Patient is unable to consent.

Sponsors & Collaborators

• Invitae Corporation: lead
• Eastern Cooperative Oncology Group: collaborator

Study Sites (1)

Invitae SF

San Francisco, California, 94103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples including EDTA tubes for germline testing, streck tubes for other analyses, and archival tissue sample from a previous biopsy or resection

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 19, 2022
• Study Start: August 23, 2021
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)