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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Under 18 years old

prisoners

unable to provide informed consent

pregnant women

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • TEG indices

    Diagnostic test

    Blood samples

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Cancer1 intervention
Group B: Control1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Haemonetics Corporation

Collaborator