Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection (TEG)

Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Esophageal Cancer; Lung Adenocarcinoma; Pancreas Cancer; Liver Cancer; Biliary Cancer; Control
• Intervention / Treatment: Diagnostic test: TEG indices

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Ivan Rodriguez, MD; Email: ivan.rodriguez@cuanschutz.edu
• Study Contact Backup: Name: Tracey MacDermott, BA BS CCRC; Phone Number: 303-724-2757; Email: tracey.macdermott@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver
      • Contact: Ivan Rodriguez, MD; Email: ivan.rodriguez@cuanschutz.edu
      • Contact: Tracey MacDermott, BA BS CCRC; Phone Number: 303-724-2757; Email: tracey.macdermott@cuanschutz.edu
      • Principal Investigator: Ana Fleisner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study
• 18 Years and older

Exclusion Criteria:

• Under 18 years old
• prisoners
• those unable to provide informed consent
• pregnant women
• and those undergoing emergent or urgent operative intervention at the time of diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer; new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma	Diagnostic test: TEG indices; Blood samples; Other Names: Control
Control; Patients undergoing major surgery	Diagnostic test: TEG indices; Blood samples; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Type	Benign, pre-malignant, malignant	One Year
Number of patients with pre-operative nodal	Benign, pre-malignant, malignant	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Haemonetics Corporation
• Investigators: Principal Investigator: Ana Gleisner, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2022
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Adenocarcinoma of Lung; Pancreatic Neoplasms; Adenocarcinoma
• Other Study ID Numbers: 17-1844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No