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Trial Title:
Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
NCT ID:
NCT05517811
Condition:
Liver Cancer
Esophageal Cancer
Colorectal Cancer
Lung Adenocarcinoma
Control
Pancreas Cancer
Biliary Cancer
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Adenocarcinoma of Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
TEG indices
Description:
Blood samples
Arm group label:
Cancer
Arm group label:
Control
Other name:
Control
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
- prisoners
- those unable to provide informed consent
- pregnant women
- and those undergoing emergent or urgent operative intervention at the time of
diagnosis
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Colorado Denver
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tracey MacDermott, BA BS CCRC
Phone:
303-724-2757
Email:
tracey.macdermott@cuanschutz.edu
Contact backup:
Last name:
Ivan Rodriguez, MD
Email:
ivan.rodriguez@cuanschutz.edu
Investigator:
Last name:
Marco Del Chiaro, MD
Email:
Principal Investigator
Start date:
June 1, 2022
Completion date:
July 31, 2028
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
Haemonetics Corporation
Agency class:
Industry
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05517811
