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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616131
• Other study ID #: 21-012
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2020
• Source: Central DuPage Hospital
• Contact: Akhil Chawla, MD
• Phone: 630-352-5353
• Email: Akhil.Chawla[@]nm.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	Northwestern Medicine Cancer Center Kishwaukee	DeKalb	Illinois
United States	Northwestern Medicine Cancer Center Delnor	Geneva	Illinois
United States	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Central DuPage Hospital	Elsa U. Pardee Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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