About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Biopsy proven metastatic disease
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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