Identify microRNAs in Cachexia in Pancreatic Carcinoma

Resectable Pancreatic Adenocarcinoma Clinical Trial

— SCC-miRPanCa  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275075
• Other study ID #: OU-SCC-MIRPANCA
• Status: Recruiting
• Start date: December 7, 2022
• Est. completion date: January 1, 2028

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: Lead Nurse
• Phone: 405.271.8777
• Email: scc-iit-office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Pancreatic Neoplasms
• Resectable Pancreatic Adenocarcinoma

Intervention

Other:
• Pancreatic cancer microRNA and messenger RNA expression.
Tumor specimens from pancreatic patients will be analyzed for markers associated with muscle loss.

Locations

Country	Name	City	State
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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