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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05275075
Other study ID # OU-SCC-MIRPANCA
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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