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2022-06-26
2028-05-31
2028-07-31
400
NCT05517811
University of Colorado, Denver
University of Colorado, Denver
OBSERVATIONAL
Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-08-04 | N/A | 2025-01-27 |
2022-08-25 | N/A | 2025-01-28 |
2022-08-26 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | One Year |
| Disease burden as measured by TNM staging | Disease burden as measured by TNM staging | One year |
| Pre- operative thrombotic and hemorrhagic complications. | Pre-operative thrombotic and hemorrhagic complications. | One Year |
| Recurrence free and overall survival. | Recurrence free and overall survival. | One Year |
| Proteomic analysis of intro-operative sample tumor microenvironment | Proteomic analysis of intro-operative sample tumor microenvironment | One Year |
| Post-operative thrombotic and hemorrhagic complications | Post-operative thrombotic and hemorrhagic complications | One Year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Tumor Type | Benign, pre-malignant, malignant | One Year |
| Number of patients with pre-operative nodal | Benign, pre-malignant, malignant | One Year |
| Number of patients withneuronal invasion | neuronal invasion | One year |
| Number of patients with mass resectability | mass resectability | One year |
| Number of patients withcomplete pathologic resection | complete pathologic resection | one year |
| Number of patients withsurgical margins | surgical margins | One year |
| blood transfusion requirements | Number of patients withblood transfusion requirements | One Year |
| pre-operative distant metastasis | Number of patients withpre-operative distant metastasis | One year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Tracey MacDermott, BA BS CCRC Phone Number: 303-724-2757 Email: tracey.macdermott@cuanschutz.edu |
Study Contact Backup Name: Ivan Rodriguez, MD Phone Number: Email: ivan.rodriguez@cuanschutz.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
