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.
Study Type
OBSERVATIONAL
Enrollment
400
Blood samples
University of Colorado Denver
Aurora, Colorado, United States
RECRUITINGTEG 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.
Time frame: One Year
Disease burden as measured by TNM staging
Disease burden as measured by TNM staging
Time frame: One year
Pre- operative thrombotic and hemorrhagic complications.
Pre-operative thrombotic and hemorrhagic complications.
Time frame: One Year
Recurrence free and overall survival.
Recurrence free and overall survival.
Time frame: One Year
Proteomic analysis of intro-operative sample tumor microenvironment
Proteomic analysis of intro-operative sample tumor microenvironment
Time frame: One Year
Post-operative thrombotic and hemorrhagic complications
Post-operative thrombotic and hemorrhagic complications
Time frame: One Year
Tumor Type
Benign, pre-malignant, malignant
Time frame: One Year
Number of patients with pre-operative nodal
Benign, pre-malignant, malignant
Time frame: One Year
Number of patients withneuronal invasion
neuronal invasion
Time frame: One year
Number of patients with mass resectability
mass resectability
Time frame: One year
Number of patients withcomplete pathologic resection
complete pathologic resection
Time frame: one year
Number of patients withsurgical margins
surgical margins
Time frame: One year
blood transfusion requirements
Number of patients withblood transfusion requirements
Time frame: One Year
pre-operative distant metastasis
Number of patients withpre-operative distant metastasis
Time frame: One year
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