Clinical trial NCT05376592: Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma
Official title: Association of Genomic Polymorphisms With Cancer Cachexia in Subjects With Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Adenocarcinoma
Cachexia
Keywords: Cancer Cachexia
Wasting Syndrome
Pancreatic Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2022-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 any LCI site may include blood or buccal swabs. Specimens may be collected during any participating LCI visit after the initial visit.

Collected and processed specimens will be stored for analysis in the Biospecimen Repository of Levine Cancer Institute (BSR) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer cachexia (CC)
timeFrame: approx. 3 months
Secondary outcomes:
measure: Cancer cachexia (CC)
timeFrame: approx. 3 months
measure: Sarcopenia
timeFrame: approx. 3 years
measure: Overall Survival (OS)
timeFrame: approx. 3 years
measure: One-year survival
timeFrame: approx. 1 year
measure: Progression free survival (PFS)
timeFrame: approx. 3 years
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Atrium Health Levine Cancer Institute
name: Kunal Kadakia, MD
role: PRINCIPAL_INVESTIGATOR
References: