Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

September 1, 2023 updated by: Inova Health Care Services
The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patients with pancreatic cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute

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

Sampling Method

Non-Probability Sample

Study Population

participants with Resectable and Borderline Resectable Pancreatic Cancer

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
  3. No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
  4. ECOG performance status ≤ 1
  5. Clinically eligible for chemotherapy
  6. Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
  7. Has residual FFPE specimen available for submission to Natera
  8. Able to read, understand and provide written informed consent
  9. Willing and able to comply with the study requirements

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. Radiologic evidence of distant metastases
  3. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
  4. Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
  5. Neuropathy > grade 2
  6. History of bone marrow or organ transplant
  7. Blood transfusion within 1 month of enrollment
  8. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
  9. Serious medical condition that may adversely affect ability to participate in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of SIGNATERA™ on treatment decisions
Time Frame: 2 years
Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of positive SIGNATERA™ ctDNA testing
Time Frame: 2 years
Determine the frequency of positive SIGNATERA™ ctDNA testing in patients with R/BR PDAC at baseline and after surgical resection
2 years
Overall survival of patients managed with SIGNATERA™ ctDNA data
Time Frame: 2 years
Compare overall survival of patients managed with available SIGNATERA™ ctDNA data to historical controls
2 years
Progression-free survival of patients managed with SIGNATERA™ ctDNA data
Time Frame: 2 years
Compare progression-free survival of patients managed with available SIGNATERA™ ctDNA data to historical controls
2 years
Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations
Time Frame: 2 years
Assess patient satisfaction regarding the potential role of SIGNATERA™ ctDNA on treatment recommendations using validated questionnaires
2 years

Collaborators and Investigators

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

Sponsor

Inova Health Care Services

Collaborators

Natera, Inc.

Investigators

  • Principal Investigator: Raymond Wadlow, MD, Inova Schar Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2022

Primary Completion (Actual)

August 23, 2023

Study Completion (Actual)

August 23, 2023

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U22-02-4671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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