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The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuroendocrine Tumor (NET) Cohort | Participants with histologically or cytologically proven diagnosis of any grade, any stage NET of gastroenteropancreatic (GEP) or lung origin; In the first stage of the study (initial 50 patients) only potential participants with stage IV, well-differentiated tumors (G1/G2) will be enrolled. |
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| Non-NET Cohort | Participants with histologically or cytologically proven diagnosis of any grade, any stage gastrointestinal (GI) malignancies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NETest | Procedure | 5 mL of blood will be drawn from participants for testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful Test Results Per Cohort | Investigators have designed the study to test the null hypothesis that the NETest has a sensitivity and specificity of 70% or less in NET patients. The sample size calculation has been based on the assumption that a sensitivity and specificity of greater than 90% would generate further interest in the test for unselected NET patients. Power and type 1 error will be 99% and 5% respectively. Under this model, 80 or more positive tests in the cohort of 100 patients with NETs would lead to the rejection of the null hypothesis, suggesting that the NETest is sensitive. Likewise, 80 or more negative tests in 100 patients without NETs will suggest that NETest is specific. An interim analysis will be performed to rule out the futility of the NETest. Futility will be defined as a rate of false positive or false negative >25%. Hence, if 12 or more false positives or negatives are observed among the first 50 participants, the study will be suspended, pending review by the investigators. | 12 months |
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Inclusion Criteria:
NET Cohort-
Non-NET Cohort -
Exclusion Criteria:
NET Cohort -
Non-NET Cohort
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Participants to be enrolled in the study will be recruited within the Gastrointestinal (GI) Clinic of Moffitt Cancer Center.
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Strosberg, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |