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

Pancreatic Cancer Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05380557
• Other study ID #: CR-001-15
• Status: Terminated
• Start date: August 23, 2021
• Est. completion date: September 6, 2022

Study information

• Verified date: December 2022
• Source: Invitae Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

Intervention

Diagnostic Test:
• Germline genetic testing
Germline genetic testing will be provided to each patient

Locations

Country	Name	City	State
United States	Invitae SF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Invitae Corporation	Eastern Cooperative Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel		Will be assessed at baseline only.
Primary	Overall survival		Will be assessed in patient and clinician surveys distributed every 4 months for the first year post germline testing
Primary	Overall survival		Will be assessed every 6 months for years 2 - 10 post germline testing