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| Name | Class |
|---|---|
| Haemonetics Corporation | INDUSTRY |
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The investigators hypothesize that abnormalities in thromboelastography (TEG) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. The investigators further hypothesize that there is histologic pathology correlates to pre-operative TEG abnormalities, and that it identifies patients with virulent tumor biology.
Aim 1: Evaluate the correlation between pre-operative TEG parameters and disease burden in patients with a new diagnosis of hepatopancreaticobiliary, esophageal, colorectal, and lung adenocarcinoma vs controls with no known malignancy.
Aim 2: Explore if pre- and post-operative TEG parameters vs routine clinical coagulation parameters (platelet count, prothrombin time [PT], partial thromboplastin time [PTT]) are predictive of pre- and post-operative thrombotic (deep vein thrombosis [DVT], pulmonary embolism [PE], stroke, myocardial infarct [MI]) and hemorrhagic complications.
Aim 3: Evaluate if correction of TEG parameters after surgery is predictive of curative resection and if the failure of TEG parameters to correct after surgery or chemoradiothearpy is predictive of cancer recurrence and overall survival.
Aim 4: Perform proteomic analyses on the tumor microenvironment of cancer tissue samples to investigate whether tumor histology and protein composition is associated with specific TEG derangements that have been previously correlated to poor outcomes, potentially identifying a specific subtype of pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer | new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma |
| |
| Control | Patients undergoing major surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEG indices | Diagnostic Test | Blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| TEG indices of coagulation | R time (minutes ~ coagulation factors), angle (degrees ~ fibrinogen function), MA (mm ~ platelets function), and LY30 (%~ fibrinolysis) measured at baseline (initial presentation or time of diagnosis), after neoadjuvant chemotherapy (if applicable), pre-operatively (before the induction of general anesthesia), intra-operatively (after tumor removal), post-operative days 1, 3 and 5, and at routine follow up appointments at 2 weeks, 3 months, 6 months and 1 year after surgery. | One Year |
| Disease burden as measured by TNM staging | Disease burden as measured by TNM staging | One year |
| Pre- operative thrombotic and hemorrhagic complications. | Pre-operative thrombotic and hemorrhagic complications. | One Year |
| Recurrence free and overall survival. | Recurrence free and overall survival. | One Year |
| Proteomic analysis of intro-operative sample tumor microenvironment | Proteomic analysis of intro-operative sample tumor microenvironment | One Year |
| Post-operative thrombotic and hemorrhagic complications | Post-operative thrombotic and hemorrhagic complications | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Type | Benign, pre-malignant, malignant | One Year |
| Number of patients with pre-operative nodal | Benign, pre-malignant, malignant |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are evaluated at the University of Colorado Cancer Center with a new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracey MacDermott, BA BS CCRC | Contact | 303-724-2757 | tracey.macdermott@cuanschutz.edu | |
| Ivan Rodriguez, MD | Contact | ivan.rodriguez@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ana Gleisner, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States |
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Blood
| One Year |
| Number of patients withneuronal invasion | neuronal invasion | One year |
| Number of patients with mass resectability | mass resectability | One year |
| Number of patients withcomplete pathologic resection | complete pathologic resection | one year |
| Number of patients withsurgical margins | surgical margins | One year |
| blood transfusion requirements | Number of patients withblood transfusion requirements | One Year |
| pre-operative distant metastasis | Number of patients withpre-operative distant metastasis | One year |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D004938 | Esophageal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
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