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

NCT05376592 | Recruiting DMC

• 2 other identifiers: IRB00083490LCI-SUPP-PDAC-CC-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreas Adenocarcinoma; Cachexia

Keywords

Cancer Cachexia; Wasting Syndrome; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cancer cachexia (CC)

  approx. 3 months

• Sarcopenia

  approx. 3 years

• Overall Survival (OS)

  approx. 3 years

• One-year survival

  approx. 1 year

• Progression free survival (PFS)

  approx. 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Atrium Health Levine Cancer Institute: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (2)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood or buccal sample

MeSH Terms

Conditions

Cachexia; Wasting Syndrome; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Kunal Kadakia, MD

  Atrium Health Levine Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CynDavia McKoy

CONTACT

704-355-2000; Cyndavia.Mckoy@advocatehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: June 17, 2022
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)