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

Colorectal Cancer Clinical Trial

— TEG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517811
• Other study ID #: 17-1844
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2023
• Source: University of Colorado, Denver
• Contact: Tracey MacDermott, BA BS CCRC
• Phone: 303-724-2757
• Email: tracey.macdermott[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Biliary Cancer
• Colorectal Cancer
• Control
• Esophageal Cancer
• Liver Cancer
• Lung Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• TEG indices
Blood samples

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Haemonetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Disease burden as measured by TNM staging	Disease burden as measured by TNM staging	One year
Primary	Pre- operative thrombotic and hemorrhagic complications.	Pre-operative thrombotic and hemorrhagic complications.	One Year
Primary	Recurrence free and overall survival.	Recurrence free and overall survival.	One Year
Primary	Proteomic analysis of intro-operative sample tumor microenvironment	Proteomic analysis of intro-operative sample tumor microenvironment	One Year
Primary	Post-operative thrombotic and hemorrhagic complications	Post-operative thrombotic and hemorrhagic complications	One Year
Secondary	Tumor Type	Benign, pre-malignant, malignant	One Year
Secondary	Number of patients with pre-operative nodal	Benign, pre-malignant, malignant	One Year
Secondary	Number of patients withneuronal invasion	neuronal invasion	One year
Secondary	Number of patients with mass resectability	mass resectability	One year
Secondary	Number of patients withcomplete pathologic resection	complete pathologic resection	one year
Secondary	Number of patients withsurgical margins	surgical margins	One year
Secondary	blood transfusion requirements	Number of patients withblood transfusion requirements	One Year
Secondary	pre-operative distant metastasis	Number of patients withpre-operative distant metastasis	One year