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

December 5, 2022 updated by: Invitae Corporation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94103
        • Invitae SF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with resectable pancreatic cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: Germline genetic testing
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.
Diagnostic test: Germline genetic testing
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.
Diagnostic test: Germline genetic testing
Germline genetic testing will be provided to each patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel
Time Frame: Will be assessed at baseline only.
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
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
Will be assessed every 6 months for years 2 - 10 post germline testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invitae Corporation

Collaborators

Eastern Cooperative Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Actual)

September 6, 2022

Study Completion (Actual)

September 6, 2022

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-001-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Germline genetic testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe