Pancreas Cancer
Conditions
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.
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.
Interventions
None listed
Sponsors
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected. | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Contacts
CONTACTStudy Coordinator
CONTACTDonald Smith, MS
PRINCIPAL_INVESTIGATORAkhil Chawla, MD
Northwestern Medicine Warrenville
Outcome results
None listed