Clinical trial NCT03568019: PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors
Official title: PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cachexia; Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically proven lung and gastrointestinal cancers

Brief summary: PET has an established role in the initial staging of patients with newly diagnosed lung and gastrointestinal tumors.PET avidity is described with both maximum and mean standardized uptake values.Malignant cells have increased activity on PET, defined as the standardized uptake value (SUV), with increased uptake of FDG in tumor due to elevated levels of GLUT receptors, elevated intracellular levels of hexokinase and increased rates of glycolysis. However, there is a subset of patients with lung and gastrointestinal tumors that are not PET avid.These patients may present with clinically and systemically aggressive disease with a declining performance status and/or weight loss.

Detailed description: This study will be a retrospective review of patients in the tumor registry with lung and gastrointestinal tumors, not limited to but including small and non-small cell lung cancers, stomach cancer, small intestinal cancer, colon cancer, rectal cancer, liver and intrahepatic bile duct cancers, gallbladder and extrahepatic bile duct cancers, and pancreatic cancer.

There will be a maximum of 10,000 charts/records that will be reviewed to compile the data. Data to be collected will include patients' name, medical record number, date of birth, race, ethnicity, gender, medical history, medications, vital and performance status, vital signs including weight and body mass index, date of cancer diagnosis, clinical and pathologic stage, pathology, treatment course, prior treatment, location of primary lesion, and smoking history. CT and PET findings to be reviewed include the number of involved lymph nodes, size of primary tumor, average/maximum PET avidity in both the primary tumor and involved lymph nodes.

Eligibility criteria: Inclusion Criteria:

Patients with histologically proven lung and gastrointestinal cancers, stages I-IV with PET and/or CT within 6 weeks of diagnosis.

Exclusion Criteria:

There will be no absolute exclusion criteria as long as the inclusion criteria have been met.

Primary outcomes:
measure: A retrospective review to determine if PET can be used to identify cachexia-inducing lung and gastrointestinal tumors
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Centre
state: Texas
Study officials:
affiliation: UTSW School of Health Professions - Clinical Nutrition Admin
name: Linda A Gilmore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UTSW Radiation Oncology
name: Orhan Oz, MS
role: PRINCIPAL_INVESTIGATOR
References: