Liver CancerTEGNCT05517811
Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
An observational study of Liver Cancer and Esophageal Cancer, run by University of Colorado, Denver at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer, Esophageal Cancer, Colorectal Cancer
- What is being tested?
- TEG indices
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jun 2022to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal, lung adenocarcinoma, or liver metastasis of any origin will be eligible for enrollment in the study
- 18 Years and older
Who cannot join
- Under 18 years old
- prisoners
- unable to provide informed consent
- pregnant women
- and those undergoing emergent or urgent operative intervention at the time of diagnosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ivan Rodriguez, MD contact
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Tracey MacDermott, BA BS CCRC, 303-724-2757, tracey.macdermott@cuanschutz.edu
Ivan Rodriguez, MD, ivan.rodriguez@cuanschutz.edu
- Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Tracey MacDermott, 303-724-2757, tracey.macdermott@cuanschutz.edu
Ana Gleisner, MD, PhD
About this study
Official title: Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG
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.
Read the 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.
- Conditions
- Liver Cancer, Esophageal Cancer, Colorectal Cancer, Lung Adenocarcinoma, Control, Pancreas Cancer
- Being tested
- TEG indices
- Medical subject headings
- Liver Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms, Adenocarcinoma of Lung, Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEG indicesDiagnostic test
Also called Control
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Cancer | new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma Receives: Diagnostic Test: TEG indices | |
| Control | Patients undergoing major surgery Receives: Diagnostic Test: TEG indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Disease burden as measured by TNM staging
Disease burden as measured by TNM staging
Measured: One year
Pre- operative thrombotic and hemorrhagic complications.
Pre-operative thrombotic and hemorrhagic complications.
Measured: One Year
Recurrence free and overall survival.
Recurrence free and overall survival.
Measured: One Year
Proteomic analysis of intro-operative sample tumor microenvironment
Proteomic analysis of intro-operative sample tumor microenvironment
Measured: One Year
Post-operative thrombotic and hemorrhagic complications
Post-operative thrombotic and hemorrhagic complications
Measured: One Year
Secondary outcomes (8)
Tumor Type
Benign, pre-malignant, malignant
Measured: One Year
Number of patients with pre-operative nodal
Benign, pre-malignant, malignant
Measured: One Year
Number of patients withneuronal invasion
neuronal invasion
Measured: One year
Number of patients with mass resectability
mass resectability
Measured: One year
Number of patients withcomplete pathologic resection
complete pathologic resection
Measured: one year
Number of patients withsurgical margins
surgical margins
Measured: One year
blood transfusion requirements
Number of patients withblood transfusion requirements
Measured: One Year
pre-operative distant metastasis
Number of patients withpre-operative distant metastasis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start26 Jun 2022
- Primary completion31 May 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Haemonetics Corporation
- Responsible party
- Sponsor
- Investigators
- Ana Gleisner, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517811
- Sponsor's protocol ID
- 17-1844
- Acronym
- TEG
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG
- ClinicalTrials.gov ID
- NCT05517811
- Acronym / sponsor ID
- TEG / 17-1844
- Conditions
- Liver Cancer, Esophageal Cancer, Colorectal Cancer, Lung Adenocarcinoma, Control, Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Haemonetics Corporation
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | Diagnostic Test: TEG indicesnew diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma |
| Control | – | Diagnostic Test: TEG indicesPatients undergoing major surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal, lung adenocarcinoma, or liver metastasis of any origin will be eligible for enrollment in the study
- 18 Years and older
Key exclusion criteria (5 listed)
- Under 18 years old
- prisoners
- unable to provide informed consent
- pregnant women
- and those undergoing emergent or urgent operative intervention at the time of diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEG indicesAlso: ControlBlood samples | Diagnostic test | Cancer, Control |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivan Rodriguez, MD contact
Ana Gleisner, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Esophageal Cancer, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracey MacDermott, BA BS CCRC (303-724-2757, tracey.macdermott@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEG indices of coagulation (time frame: One Year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.