Biliary Cancer, Colorectal Cancer, Control, Esophageal Cancer, Liver Cancer, Lung Adenocarcinoma, Pancreas Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTTEG indices
Blood samples
Sponsors
University of Colorado, Denver
Haemonetics Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal, lung adenocarcinoma, or liver metastasis of any origin will be eligible for enrollment in the study * 18 Years and older
Exclusion criteria
* Under 18 years old * prisoners * unable to provide informed consent * pregnant women * and those undergoing emergent or urgent operative intervention at the time of diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEG indices of coagulation | One Year | 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. |
| Disease burden as measured by TNM staging | One year | Disease burden as measured by TNM staging |
| Pre- operative thrombotic and hemorrhagic complications. | One Year | Pre-operative thrombotic and hemorrhagic complications. |
| Recurrence free and overall survival. | One Year | Recurrence free and overall survival. |
| Proteomic analysis of intro-operative sample tumor microenvironment | One Year | Proteomic analysis of intro-operative sample tumor microenvironment |
| Post-operative thrombotic and hemorrhagic complications | One Year | Post-operative thrombotic and hemorrhagic complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Type | One Year | Benign, pre-malignant, malignant |
| Number of patients with pre-operative nodal | One Year | Benign, pre-malignant, malignant |
| Number of patients withneuronal invasion | One year | neuronal invasion |
| Number of patients with mass resectability | One year | mass resectability |
| Number of patients withcomplete pathologic resection | one year | complete pathologic resection |
| Number of patients withsurgical margins | One year | surgical margins |
| blood transfusion requirements | One Year | Number of patients withblood transfusion requirements |
| pre-operative distant metastasis | One year | Number of patients withpre-operative distant metastasis |
Countries
United States
Contacts
CONTACTTracey MacDermott, BA BS CCRC
CONTACTIvan Rodriguez, MD
PRINCIPAL_INVESTIGATORAna Gleisner, MD
University of Colorado, Denver
Outcome results
None listed