Evaluating the Response to Neoadjuvant Chemotherapy With Circulating Tumor DNA in Pancreatic Cancer

For patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. The purpose of this research study is to understand if we are able to detect pancreatic cancer DNA in the blood stream before, during, and after treatment.

Study Overview

• Status: Unknown
• Conditions: Pancreas Cancer

Detailed Description

Cancer DNA in the blood stream is called circulating tumor DNA or ctDNA. The presence or absence of pancreatic cancer ctDNA in the blood stream may help clinicians to better understand pancreatic cancer behavior in response to specific treatments, like chemotherapy and surgery. Understanding how treatment alters the ctDNA can help future patients diagnosed with pancreatic cancer. The presence or absence of ctDNA or the clearance of ctDNA after treatment may help to guide further treatment decisions for cancer patients after surgery.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Akhil Chawla, MD; Phone Number: 630-352-5353; Email: Akhil.Chawla@nm.org
• Study Contact Backup: Name: Donald Smith, MS; Phone Number: 630-352-5360; Email: Donald.Smith3@nm.org

Study Locations

• United States
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • Recruiting
      • Northwestern Medicine Cancer Center Kishwaukee
      • Contact: Donald Smith; Phone Number: 630-352-5360; Email: donald.smith3@nm.org
      • Sub-Investigator: Robert Bayer, MD
      • Sub-Investigator: Faisal Saghir, MD
    • Geneva, Illinois, United States, 60135
      • Recruiting
      • Northwestern Medicine Cancer Center Delnor
      • Contact: Donald Smith; Phone Number: 630-352-5360; Email: donald.smith3@nm.org
      • Sub-Investigator: Christopher George, MD
      • Sub-Investigator: Habib Shaikh, DO
      • Sub-Investigator: Arlene D'Souza, MD
    • Warrenville, Illinois, United States, 60555
      • Recruiting
      • Northwestern Medicine Cancer Center Warrenville
      • Contact: Akhil Chawla, MD; Phone Number: 630-352-5353; Email: Akhil.Chawla@nm.org
      • Sub-Investigator: Ahamed Zarzour, MD
      • Sub-Investigator: Kevin Dawravoo, MD
      • Sub-Investigator: John Abad, MD

Participation Criteria

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

Male or female individuals age 18 and over planning to receive chemotherapy for pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes.

Description

Inclusion Criteria:

• Biopsy or cytology proven adenocarcinoma of the pancreas
• No clinical evidence of metastatic disease on imaging
• Age 18 or older
• Receiving chemotherapy for non-metastatic pancreatic cancer

Exclusion Criteria:

• Biopsy proven metastatic disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected.	Utilizing Tempus, a commercial laboratory ctDNA genetic profile panel investigators will analyze the number of patients who had detectable ctDNA in their blood prior to neoadjuvant chemotherapy who then had no detectable ctDNA after their chemotherapy treatment.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigators will look for statistically significant correlations of ctDNA blood levels with clinical treatment responses of tumor grades, CA 19-9 units/milliliter blood level, and radiologic response by RECIST categories of complete response.	Association of ctDNA clearance with the following: pathologic treatment response per CAP tumor regression grade 0,1,2, and 3, blood level measurement of protein CA 19-9 units/milliliter, and radiologic response by tumor measurements in mm and using RECIST tumor measurement categories of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) for all patients, and margin assessment (R0/R1 resection) in resected patients.	12 months

Collaborators and Investigators

• Sponsor: Central DuPage Hospital
• Collaborators: Elsa U. Pardee Foundation
• Investigators: Principal Investigator: Akhil Chawla, MD, Northwestern Medicine Central DuPage Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (ACTUAL): November 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 21-012

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