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2022-12-07
2026-05-01
2029-05-01
100
NCT05275075
University of Oklahoma
University of Oklahoma
OBSERVATIONAL
Identify microRNAs in Cachexia in Pancreatic Carcinoma
The purpose of this study is to determine the proportion of pancreatic patients who experience weight loss and cachexia, and to identify any differences in the genes between patient groups.
This research study will retrospectively examine 1395 patients from the University of Alabama and the University of Oklahoma Stephenson Cancer Center (OU-SCC) pancreatic cancer cohorts. The prospective arm, will enroll a total of 100 eligible volunteers at the OU-SCC. The demographic and medical data from the retrospective and prospective arms will be combined (1495 patients) to ascertain any racial disparities in pancreatic cancer patients with cachexia. Perspective volunteers at the OU-SCC will undergo routine tests to determine if their cancer is operable. Pancreatic tumors will be removed from the eligible patients, as part of their normal standard of care and will be examined for genes that may be related to unexplained muscle loss and compared to tumor tissue from other patients with pancreatic cancer. An optional hand strength exam, and standing on a scale that measures weight, muscle, and body fat will be available to OU-SCC patients.
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 |
|---|---|---|
2022-03-02 | N/A | 2025-02-07 |
2022-03-02 | N/A | 2025-02-11 |
2022-03-11 | N/A | 2025-02 |
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 |
|---|---|
| : Pancreatic Cancer Cohort All eligible adenocarcinoma pancreatic cancer patients with operable cancer. | OTHER: Pancreatic cancer microRNA and messenger RNA expression.
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Proportion of African American pancreatic cancer patients with weight loss and cachexia. | Evaluate weight loss and the markers of cachexia, albumin and psoas cross-sectional area, to see if African Americans with pancreatic cancer patients experience Grade I-IV cachexia at a higher frequency than other racial groups. | 1 - 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Differences in microRNA and messenger RNA tumor expression profiles in all cancer patients undergoing pancreatic surgery. | Assess fold-change expression differences in microRNA and messenger RNA tumor expression profiles in all cancer patients undergoing pancreatic surgery. | 1 - 12 months |
| Differences in cachexia-associated RNA signatures in African American pancreatic cancer patients, and other racial groups. | Assess fold-change expression differences in cachexia-associated RNA signatures in African American pancreatic cancer patients, and other racial groups. | 1 - 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Lead Nurse Phone Number: 405.271.8777 Email: scc-iit-office@ouhsc.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:
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
