Clinical trial NCT05517811: Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
Official title: Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Esophageal Cancer
Colorectal Cancer
Lung Adenocarcinoma
Control
Pancreas Cancer
Biliary Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Haemonetics Corporation
First posted: 2022-08-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: TEG indices of coagulation
timeFrame: One Year
measure: Disease burden as measured by TNM staging
timeFrame: One year
measure: Pre- operative thrombotic and hemorrhagic complications.
timeFrame: One Year
measure: Recurrence free and overall survival.
timeFrame: One Year
measure: Proteomic analysis of intro-operative sample tumor microenvironment
timeFrame: One Year
measure: Post-operative thrombotic and hemorrhagic complications
timeFrame: One Year
Secondary outcomes:
measure: Tumor Type
timeFrame: One Year
measure: Number of patients with pre-operative nodal
timeFrame: One Year
measure: Number of patients withneuronal invasion
timeFrame: One year
measure: Number of patients with mass resectability
timeFrame: One year
measure: Number of patients withcomplete pathologic resection
timeFrame: one year
measure: Number of patients withsurgical margins
timeFrame: One year
measure: blood transfusion requirements
timeFrame: One Year
measure: pre-operative distant metastasis
timeFrame: One year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Ana Gleisner, MD
role: PRINCIPAL_INVESTIGATOR
References: