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Recruiting NCT05517811

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

— Observational Liver Cancer Esophageal Cancer Colorectal Cancer Lung Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TEG indices.
Who it may be relevant to
Registry conditions: Liver Cancer, Esophageal Cancer, Colorectal Cancer, Lung Adenocarcinoma. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 test TEG indices
    Blood samples

Primary outcome measures

  • TEG indices of coagulation [Time frame: One Year]
  • Disease burden as measured by TNM staging [Time frame: One year]
  • Pre- operative thrombotic and hemorrhagic complications. [Time frame: One Year]
  • Recurrence free and overall survival. [Time frame: One Year]
  • Proteomic analysis of intro-operative sample tumor microenvironment [Time frame: One Year]
  • Post-operative thrombotic and hemorrhagic complications [Time frame: One Year]
Secondary outcome measures (8)
  • Tumor Type [Time frame: One Year]
  • Number of patients with pre-operative nodal [Time frame: One Year]
  • Number of patients withneuronal invasion [Time frame: One year]
  • Number of patients with mass resectability [Time frame: One year]
  • Number of patients withcomplete pathologic resection [Time frame: one year]
  • Number of patients withsurgical margins [Time frame: One year]
  • blood transfusion requirements [Time frame: One Year]
  • pre-operative distant metastasis [Time frame: One year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Colorado Denver — Aurora

Identifiers

NCT: NCT05517811 · 17-1844

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗