Identify microRNAs in Cachexia in Pancreatic Carcinoma

Recruiting

• Conditions: Resectable Pancreatic Adenocarcinoma
• Interventions: Other: Pancreatic cancer microRNA and messenger RNA expression.

• Registration Number: NCT05275075
• Lead Sponsor: University of Oklahoma

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-12-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-05-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female patient, who is ≥ 18 years old at the time of informed consent.
2. Patients with operable pancreatic tumors diagnosed in the last 12 months prior to consent with clinical discretion or pathology confirmed as adenocarcinoma.
3. Patient has stage I or higher disease who is considered a candidate for surgical resection of pancreatic cancer, with or without neoadjuvant chemotherapy.
4. Ability to provide written informed consent and HIPAA authorization.

Exclusion Criteria

1. Patients with pancreatic adenocarcinoma who do not meet the criteria for surgical resection.
2. Patient has cancer diagnosis other than primary pancreatic adenocarcinoma.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatic Cancer Cohort	Pancreatic cancer microRNA and messenger RNA expression.	All eligible adenocarcinoma pancreatic cancer patients with operable cancer.

Primary Outcome Measures

Name	Time	Method
Proportion of African American pancreatic cancer patients with weight loss and cachexia.	1 - 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Differences in microRNA and messenger RNA tumor expression profiles in all cancer patients undergoing pancreatic surgery.	1 - 12 months	Assess fold-change expression differences in microRNA and messenger RNA tumor expression profiles in all cancer patients undergoing pancreatic surgery.
Differences in cachexia-associated RNA signatures in African American pancreatic cancer patients, and other racial groups.	1 - 12 months	Assess fold-change expression differences in cachexia-associated RNA signatures in African American pancreatic cancer patients, and other racial groups.

Trial Locations

Locations (1)

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States