Identify microRNAs in Cachexia in Pancreatic Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Trial to Identify microRNAs in Cachexia in Patients With Pancreatic Carcinoma

Conditions
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Resectable Pancreatic Adenocarcinoma

Intervention / Treatment
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* Other: Pancreatic cancer microRNA and messenger RNA expression.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient, who is ≥ 18 years old at the time of informed consent. Patients with operable pancreatic tumors diagnosed in the last 12 months prior to consent with clinical discretion or pathology confirmed as adenocarcinoma. Patient has stage I or higher disease who is considered a candidate for surgical resection of pancreatic cancer, with or without neoadjuvant chemotherapy. Ability to provide written informed consent and HIPAA authorization. Exclusion Criteria: Patients with pancreatic adenocarcinoma who do not meet the criteria for surgical resection. Patient has cancer diagnosis other than primary pancreatic adenocarcinoma.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic Cancer Cohort<br>All eligible adenocarcinoma pancreatic cancer patients with operable cancer. | Other: Pancreatic cancer microRNA and messenger RNA expression.<br>* Tumor specimens from pancreatic patients will be analyzed for markers associated with muscle loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mRNA, pancreatic cancer, cachexia, microRNA, PDAC