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NCT Number: NCT05517811

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

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.

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Key information

Conditions

Liver Cancer Adenocarcinoma Adenocarcinoma of Lung Biliary Cancer Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms Control Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Adenocarcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Ana Fleisner, MD

PRINCIPAL_INVESTIGATOR

Ivan Rodriguez, MD

CONTACT

[email protected]

Tracey MacDermott, BA BS CCRC

CONTACT

[email protected]

303-724-2757

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEG indices

Diagnostic Test

Blood samples

Other names: Control

Primary outcomes

  1. TEG indices of coagulation

    Time frame: 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.

  2. Disease burden as measured by TNM staging

    Time frame: One year

    Disease burden as measured by TNM staging

  3. Pre- operative thrombotic and hemorrhagic complications.

    Time frame: One Year

    Pre-operative thrombotic and hemorrhagic complications.

  4. Recurrence free and overall survival.

    Time frame: One Year

    Recurrence free and overall survival.

  5. Proteomic analysis of intro-operative sample tumor microenvironment

    Time frame: One Year

    Proteomic analysis of intro-operative sample tumor microenvironment

  6. Post-operative thrombotic and hemorrhagic complications

    Time frame: One Year

    Post-operative thrombotic and hemorrhagic complications

Secondary outcomes

  1. Tumor Type

    Time frame: One Year

    Benign, pre-malignant, malignant

  2. Number of patients with pre-operative nodal

    Time frame: One Year

    Benign, pre-malignant, malignant

  3. Number of patients withneuronal invasion

    Time frame: One year

    neuronal invasion

  4. Number of patients with mass resectability

    Time frame: One year

    mass resectability

  5. Number of patients withcomplete pathologic resection

    Time frame: one year

    complete pathologic resection

  6. Number of patients withsurgical margins

    Time frame: One year

    surgical margins

  7. blood transfusion requirements

    Time frame: One Year

    Number of patients withblood transfusion requirements

  8. pre-operative distant metastasis

    Time frame: One year

    Number of patients withpre-operative distant metastasis

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Rodriguez, MD

CONTACT

[email protected]

Tracey MacDermott, BA BS CCRC

CONTACT

[email protected]

303-724-2757

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Haemonetics Corporation

Registry information

Official study title

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

Acronym: TEG

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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