ClinicalTrials.gg
RecruitingNCT05517811TEGUpdated Aug 24, 2026

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

An observational study in Liver Cancer, Esophageal Cancer and Colorectal Cancer, sponsored by University of Colorado, Denver. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by University of Colorado, Denver · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 566 studies in Liver Neoplasms with a site in United States — 83 open to participants now, 122 under way, 6 of them phase 3. Liver Neoplasms · United States.

Planned enrollment
47th of 111
200 · median 143
Started
2022
with 21 others
Observational
111 of 566
25 open now
Primary completion
2028-05
later than 87 of 119 live
Registered
485th of 566
by date

Among the 566 studies in Liver Neoplasms with a site in United States, this one is the 47th largest by planned enrollment of the 111 observational ones that give a count, is one of 22 that started in 2022, is one of 111 observational ones, reaches primary completion later than 87 of the 119 other live ones, and was the 485th registered.

Liver Neoplasms

1,345 studies on the registry are indexed under Liver Neoplasms; 335 are open to participants now.

Browse Liver Neoplasms studies →

Open to participants now

83 of the 566 studies in Liver Neoplasms with a site in United States are open now. Recruiting first, the newest first:

78 more — sign in →

All 83 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 244 Liver Neoplasms studies recruiting now, 138 (57%) set no upper age limit and 69 (28%) stop at 75 or younger; 14 take children under 18; 34 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · healthy volunteers too.

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02

Study 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.

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.

03

Conditions studied

  • Liver Cancer
  • Esophageal Cancer
  • Colorectal Cancer
  • Lung Adenocarcinoma
  • Control
  • Pancreas Cancer
  • Biliary Cancer
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 18 years old
  • prisoners
  • unable to provide
  • pregnant women
  • and those undergoing emergent or urgent operative intervention at the time of diagnosis
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testTEG indices

    Blood samples

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One Year

  2. Disease burden as measured by TNM staging

    Disease burden as measured by TNM staging

    Time frame: One year

  3. Pre- operative thrombotic and hemorrhagic complications.

    Pre-operative thrombotic and hemorrhagic complications.

    Time frame: One Year

  4. Recurrence free and overall survival.

    Recurrence free and overall survival.

    Time frame: One Year

  5. Proteomic analysis of intro-operative sample tumor microenvironment

    Proteomic analysis of intro-operative sample tumor microenvironment

    Time frame: One Year

  6. Post-operative thrombotic and hemorrhagic complications

    Post-operative thrombotic and hemorrhagic complications

    Time frame: One Year

Secondary outcomes

  1. Tumor Type

    Benign, pre-malignant, malignant

    Time frame: One Year

  2. Number of patients with pre-operative nodal

    Benign, pre-malignant, malignant

    Time frame: One Year

  3. Number of patients withneuronal invasion

    neuronal invasion

    Time frame: One year

  4. Number of patients with mass resectability

    mass resectability

    Time frame: One year

  5. Number of patients withcomplete pathologic resection

    complete pathologic resection

    Time frame: one year

  6. Number of patients withsurgical margins

    surgical margins

    Time frame: One year

  7. blood transfusion requirements

    Number of patients withblood transfusion requirements

    Time frame: One Year

  8. pre-operative distant metastasis

    Number of patients withpre-operative distant metastasis

    Time frame: One year

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for May 2028, 71 months after the start.

Of 132 non-industry observational studies under Liver Neoplasms, half reached primary completion within 114 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 172. This study's planned 71 months is below that.

Counting every sponsor, half of 160 studies reached it within 59 months; a quarter within 34 and three quarters within 172.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2022
First posted
Aug 26, 2022
StartActual
Jun 26, 2022
Primary completionEst.
May 31, 2028
CompletionEst.
Jul 31, 2028
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05517811
Collaborators
Haemonetics Corporation
Responsible party
Sponsor
First posted
Aug 26, 2022
Start date
Jun 26, 2022
Primary completion
May 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Aug 24, 2026

Study contacts

Tracey MacDermott, BA BS CCRC
Contact
tracey.macdermott@cuanschutz.edu
303-724-2757
Ivan Rodriguez, MD
Contact
ivan.rodriguez@cuanschutz.edu
Ana Gleisner, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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