Evaluating The Response To Neoadjuvant Chemotherapy With Circulating Tumor DNA In Pancreatic Cancer

Study Overview

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.

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.

Pancreas Cancer

21-012

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-10-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-10-30
First Submitted that Met QC Criteria 2020-10-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-11-04
First Posted (ACTUAL) 2020-11-04	Results First Posted N/A	Last Verified 2020-10

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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	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

Contacts and Locations

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

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Biopsy proven metastatic disease

Collaborators and Investigators

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

Elsa U. Pardee Foundation

Investigators

PRINCIPAL_INVESTIGATOR: Akhil Chawla, MD, Northwestern Medicine Central DuPage Hospital

Publications

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

General Publications

No publications available

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Clinical Trial Record