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This is a study that aims to understand whether a blood test measuring tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) shows a similar response as observed by a follow-up CT scan. To study this question, ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) | Diagnostic Test | ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| First follow-up imaging assessment | Compare first follow-up imaging assessment at 2 months with tumor response as assessed by ctDNA level change from baseline | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA Assessment Comparison | Compare ctDNA assessment at 2 months with earlier ctDNA measurements | 2 months |
| Compare Signatera ctDNA test | Compare Signatera ctDNA test with another vendor |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory - Organoid Samples | If organoid samples are available, compare drug response assessment from organoids to clinical response assessment at 2 months. | 2 months |
| Exploratory - Sample Size | If sample size has enough power, to compare differences in early ctDNA response between regimens (FOLFIRINOX vs Gemcitabine-based treatment, at 3 days and 1 week, respectively) |
Inclusion Criteria:
Prior/Concurrent Therapy Criteria
Patients must be initiating a new treatment regimen for pancreatic cancer at the time of their initiation in the study
Patients must have cytologic or histologic confirmation of pancreatic cancer
Patients must have measurable radiographic evidence of metastatic disease
Patients must be ≥18 years of age
Patients must have an ECOG Performance Status 0-2.
Patients must have adequate organ function for delivery of chemotherapy as evidenced by the following: Hgb ≥8 g/dL, platelets ≥ 75
Patients must not have renal dysfunction that would prevent administration of IV contrast for radiographic assessment.
Regulatory Criteria
Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
Patients of all races, genders, & ethnicities are eligible.
Exclusion Criteria:
No exclusion criteria.
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The proposed sample size of 20 subjects is based on feasibility and availability of resources and not on a formal power calculation. The number of subjects is small, so as to quickly gather data that could inform a larger study.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel King, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg Cancer Center | New Hyde Park | New York | 11042 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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ctDNA
| 6 months |
| ctDNA, CA19-9, & CEA Response | Compare response of ctDNA with response of CA19-9 and CEA | 6 months |
| 6 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |