NCT05517811 · University of Colorado, Denver
Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
(TEG)
What this study is about
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 how long patients live as well as thrombotic and hemorrhagic post-operative complications.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
TEG indices
Blood samples
Primary outcome measures
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.
Disease burden as measured by TNM staging
Time frame: One year
Disease burden as measured by TNM staging
Pre- operative thrombotic and hemorrhagic complications.
Time frame: One Year
Pre-operative thrombotic and hemorrhagic complications.
Recurrence free and overall survival.
Time frame: One Year
Recurrence free and overall survival.
Proteomic analysis of intro-operative sample tumor microenvironment
Time frame: One Year
Proteomic analysis of intro-operative sample tumor microenvironment
Post-operative thrombotic and hemorrhagic complications
Time frame: One Year
Post-operative thrombotic and hemorrhagic complications
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- those unable to provide informed consent
- pregnant women
- and those undergoing emergent or urgent operative intervention at the time of diagnosis
Where
- Aurora, Colorado
Collaborators
Haemonetics Corporation
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced Jan 28, 2025 · Source of record for eligibility and locations