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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Biliary Cancer; Esophageal Cancer; Pancreas Cancer; Control; Liver Cancer; Lung Adenocarcinoma; Colorectal Cancer

Treatments: Diagnostic Test: TEG indices

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05517811

17-1844

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Cancer

Description:

new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma

Treatment:

Diagnostic Test: TEG indices

Control

Description:

Patients undergoing major surgery

Treatment:

Diagnostic Test: TEG indices