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

NCT05517811 | Recruiting

• 1 other identifier: 17-1844
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• Disease burden as measured by TNM staging

  Disease burden as measured by TNM staging

  One year

• Pre- operative thrombotic and hemorrhagic complications.

  Pre-operative thrombotic and hemorrhagic complications.

  One Year

• Recurrence free and overall survival.

  Recurrence free and overall survival.

  One Year

• Proteomic analysis of intro-operative sample tumor microenvironment

  Proteomic analysis of intro-operative sample tumor microenvironment

  One Year

• Post-operative thrombotic and hemorrhagic complications

  Post-operative thrombotic and hemorrhagic complications

  One Year

Secondary Outcomes (8)

• Tumor Type

  One Year

• Number of patients with pre-operative nodal

  One Year

• Number of patients withneuronal invasion

  One year

• Number of patients with mass resectability

  One year

• Number of patients withcomplete pathologic resection

  one year

Study Arms (2)

Cancer

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

Diagnostic Test: TEG indices

Control

Patients undergoing major surgery

Diagnostic Test: TEG indices

Interventions

TEG indices DIAGNOSTIC_TEST

Blood samples

Also known as: Control

Cancer; Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study
• Years and older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Haemonetics Corporation: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Liver Neoplasms; Esophageal Neoplasms; Colorectal Neoplasms; Adenocarcinoma of Lung; Pancreatic Neoplasms; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ana Gleisner, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracey MacDermott, BA BS CCRC

CONTACT

303-724-2757; tracey.macdermott@cuanschutz.edu

Ivan Rodriguez, MD

CONTACT

ivan.rodriguez@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 26, 2022
• Study Start: June 26, 2022
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)