Clinical trial NCT05275075: Identify microRNAs in Cachexia in Pancreatic Carcinoma
Official title: Pilot Trial to Identify microRNAs in Cachexia in Patients With Pancreatic Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Resectable Pancreatic Adenocarcinoma
Keywords: pancreatic cancer
cachexia
microRNA
mRNA
PDAC
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of African American pancreatic cancer patients with weight loss and cachexia.
timeFrame: 1 - 12 months
Secondary outcomes:
measure: Differences in microRNA and messenger RNA tumor expression profiles in all cancer patients undergoing pancreatic surgery.
timeFrame: 1 - 12 months
measure: Differences in cachexia-associated RNA signatures in African American pancreatic cancer patients, and other racial groups.
timeFrame: 1 - 12 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Stephenson Cancer Center
name: Ajay Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: