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

NCT ID: NCT05380557

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2022-09-06

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.

Conditions

Pancreatic Adenocarcinoma; Pancreatic Cancer; Resectable Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Germline genetic testing

Intervention Type: DIAGNOSTIC_TEST

Germline genetic testing will be provided to each patient

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.

Germline genetic testing

Intervention Type: DIAGNOSTIC_TEST

Germline genetic testing will be provided to each patient

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.

Germline genetic testing

Intervention Type: DIAGNOSTIC_TEST

Germline genetic testing will be provided to each patient

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.

Germline genetic testing

Intervention Type: DIAGNOSTIC_TEST

Germline genetic testing will be provided to each patient

Interventions

Germline genetic testing

Germline genetic testing will be provided to each patient

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

Invitae Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Invitae SF

San Francisco, California, United States

Countries

United States

Other Identifiers

CR-001-15

Identifier Type: -

Identifier Source: org_study_id