Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma

Association of Genomic Polymorphisms With Cancer Cachexia in Subjects With Pancreatic Adenocarcinoma

A major complication of pancreatic adenocarcinoma (PDAC) is cancer cachexia (CC) which is a complex syndrome characterized by skeletal muscle mass loss (with or without loss of fat mass) and progressive functional impairment not reversible by conventional nutritional support. It is estimated to occur in over 75% of patients with advanced PDAC, the highest incidence of all solid tumors, and contributes significantly to poor outcomes and mortality. Though there is overlap amongst the pathophysiologic studies evaluating CC in murine models of different tumor types, the high prevalence of CC within gastrointestinal (GI) malignancies and specifically PDAC suggest that dedicated studies evaluating polymorphisms in candidate genes specific to PDAC warrant further evaluation. The collection and analysis of specimens under this study will facilitate the identification and characterization of genomic polymorphisms associated with CC in PDAC patients. Subsequently, this data may help contribute towards diagnostic and therapeutic treatments that may improve patient outcomes.

Study Overview

• Status: Recruiting
• Conditions: Cachexia; Pancreas Adenocarcinoma

Detailed Description

This pilot study consists of a cohort of 100 locally advanced unresectable or metastatic PDAC subjects with a prospective analysis of biomarkers that may be associated with CC, a major negative prognostic factor in outcomes.

The study protocol-directed assessments consist of four experimental measures (gene single nucleotide polymorphisms and available clinical information including weights, imaging review of sarcopenia, and select labs) used to determine factors that potentially contribute to CC in subjects with PDAC. Main confounding factors to be evaluated include stage of disease, receipt of anti-cancer therapies, and sites of metastatic disease.

Specimens collected from PDAC patients treated at Atrium Health Wake Forest Baptist Comprehensive Cancer Center may include blood or buccal swabs. Specimens may be collected during any standard of care clinic visit after screening and confirmation of eligibility.

Collected and processed specimens will be stored for analysis at Atrium Health and analyzed in the Nutrition Research Institute (NRI). All specimen results will remain deidentified. Personal health information will be collected on study participants and linked to results of genomic analysis but will be deidentified prior to any data analysis and presentation at scientific conferences, sharing with non-Atrium Health investigators and for publications.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: CynDavia McKoy; Phone Number: 704-355-2000; Email: Cyndavia.Mckoy@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
      • Principal Investigator: Kunal Kadakia, MD
      • Contact: CynDavia McKoy; Phone Number: 704-355-2000; Email: Cyndavia.Mckoy@advocatehealth.org
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
      • Contact: Ravi Paluri, MD; Email: rpaluri@wakehealth.edu

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

Subjects with pancreatic adenocarcinoma will be will be approached for potential consent during a clinic visit at any participating Levine Cancer Institute location.

Description

Inclusion Criteria:

Subject must meet all of the following applicable inclusion criteria to participate in this study:

• Written informed consent and HIPAA authorization for release of personal health information by the subject in accordance with the practices of the Levine Cancer Institute and Atrium Health. NOTE: HIPAA authorization will be included in the informed consent.
• Male or female patients age ≥ 18 years at the time of consent
• Histological or cytological confirmation of pancreatic adenocarcinoma, with a diagnosis of locally advanced unresectable PDAC (LAPC) or metastatic pancreatic adenocarcinoma. LAPC is defined as per NCCN 16. Note: Subject can be enrolled at any time during their cancer course following histologic diagnosis.
• Able to provide a blood or buccal sample.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer cachexia (CC)	A binary variable will be determined for each subject indicating if they have developed CC within 3 months after diagnosis as defined as weight loss of at least 5%.	approx. 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer cachexia (CC)	A binary variable will be determined for each subject indicating if they have developed CC within 3 months after diagnosis as defined as weight loss of at least 10%.	approx. 3 months
Sarcopenia	A binary variable will be determined for each subject indicating if they have developed sarcopenia at any point in time of or after diagnosis. Measurements of sarcopenia will be obtained via body composition analysis of available, routine CT and/or MRI imaging.	approx. 3 years
Overall Survival (OS)	Overall survival is defined as the duration of time from the date of diagnosis to the date of death from any cause.	approx. 3 years
One-year survival	One-year survival will be determined as a binary variable for each subject indicating if the subject is alive one year after the date of diagnosis.	approx. 1 year
Progression free survival (PFS)	Progression free survival is defined as the duration from date of diagnosis to first occurrence of either progressive disease or death.	approx. 3 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Levine Cancer Institute
• Investigators: Principal Investigator: Kunal Kadakia, MD, Atrium Health Levine Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Cancer Cachexia; Wasting Syndrome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Neoplasms by Site; Neoplasms; Metabolic Diseases; Body Weight; Body Weight Changes; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pancreatic Neoplasms; Wasting Syndrome; Cachexia
• Other Study ID Numbers: IRB00083490; LCI-SUPP-PDAC-CC-001 (Other Identifier: Atrium Health)

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