Identify microRNAs in Cachexia in Pancreatic Carcinoma (SCC-miRPanCa)

Pilot Trial to Identify microRNAs in Cachexia in Patients With 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.

Study Overview

• Status: Terminated
• Conditions: Resectable Pancreatic Adenocarcinoma
• Intervention / Treatment: Other: Pancreatic cancer microRNA and messenger RNA expression.

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • Stephenson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is inclusive of all races, ethnicities, and gender. Enrollment into the study is restricted to Stephenson Cancer Center site, part of the University Oklahoma Health Sciences Center.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pancreatic Cancer Cohort; All eligible adenocarcinoma pancreatic cancer patients with operable cancer.	Other: Pancreatic cancer microRNA and messenger RNA expression.; Tumor specimens from pancreatic patients will be analyzed for markers associated with muscle loss.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Ajay Jain, MD, University of Oklahoma Stephenson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): April 3, 2026
• Study Completion (Actual): April 3, 2026

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: microRNA; pancreatic cancer; mRNA; cachexia; PDAC
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Body Weight; Body Weight Changes; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pancreatic Neoplasms; Cachexia
• Other Study ID Numbers: OU-SCC-MIRPANCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No