Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Subjects with pancreatic adenocarcinoma will be will be approached for potential consent during a clinic visit at any participating Levine Cancer Institute location.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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%.
Time frame
approx. 3 monthsSecondary 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 10%.
Time frame
approx. 3 months2
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.
Time frame
approx. 3 years3
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.
Time frame
approx. 3 years4
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.
Time frame
approx. 1 yearSponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
Source ClinicalTrials.gov