Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma
Recruiting · NCT05376592 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 1 US state.
- Levine Cancer Institute - Charlotte, North Carolina, United States
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem, North Carolina, United States