Evaluating the Prognostic Capability of ctDNA as a Biomarker in Pancreatic Cancer Patients Undergoing Neoadjuvant Chemotherapy
1 other identifier
observational
500
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
June 18, 2026
June 1, 2026
7 years
October 21, 2020
June 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
12 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Biopsy proven metastatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60135, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Akhil Chawla, MD
Northwestern Medicine Warrenville
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2020
First Posted
November 4, 2020
Study Start
October 1, 2020
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2029
Last Updated
June 18, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share