Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

Withdrawn

• Conditions: Pancreatic Cancer

• Registration Number: NCT05379907
• Lead Sponsor: Inova Health Care Services

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-18
• Study Start: 2022-08-23
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of SIGNATERA™ on treatment decisions	2 years	Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inova Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States