Evaluating the Prognostic Capability of ctDNA as a Biomarker in Pancreatic Cancer Patients Undergoing Neoadjuvant Chemotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNorthwestern University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
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.

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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