Pancreas AdenocarcinomaNCT05376592
Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma
An observational study of Pancreas Adenocarcinoma and Cachexia, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma, Cachexia
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2022to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
CynDavia McKoy, 704-355-2000, Cyndavia.Mckoy@advocatehealth.org
Kunal Kadakia, MD
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27103
Ravi Paluri, MD, rpaluri@wakehealth.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreas Adenocarcinoma, Cachexia
- Keywords
- Cancer Cachexia, Wasting Syndrome, Pancreatic Cancer
- Medical subject headings
- Cachexia, Wasting Syndrome, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: approx. 3 months
Secondary outcomes (5)
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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: approx. 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start17 Jun 2022
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Kunal Kadakia, MD, Principal investigator, Atrium Health Levine Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376592
- Sponsor's protocol ID
- IRB00083490
- Other IDs
- LCI-SUPP-PDAC-CC-001
- Status last verified
- Jul 2026
- First submitted
- 11 May 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Genomic Polymorphisms With Cancer Cachexia in Subjects With Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05376592
- Acronym / sponsor ID
- IRB00083490
- Conditions
- Pancreas Adenocarcinoma, Cachexia
- Keywords
- Cancer Cachexia, Wasting Syndrome, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer cachexia (CC)
Time frame: approx. 3 months
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%.
5 secondary outcomes
Cancer cachexia (CC)
Time frame: approx. 3 months
Sarcopenia
Time frame: approx. 3 years
Overall Survival (OS)
Time frame: approx. 3 years
One-year survival
Time frame: approx. 1 year
Progression free survival (PFS)
Time frame: approx. 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kunal Kadakia, MD principal investigator
Atrium Health Levine Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Adenocarcinoma and Cachexia, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CynDavia McKoy (704-355-2000, Cyndavia.Mckoy@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer cachexia (CC) (time frame: approx. 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.