A First-in-Human Study of FID-022 in Solid Tumor Patients
Recruiting · NCT07249775 · Observational (researchers observe without assigning treatment) · Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Baseline Lifestyle and Symptom AssessmentExtended Lifestyle MonitoringFeasibility Survey
What this trial is about
This observational study aims to (1) validate a multimodal artificial intelligence (AI) model for early detection of cancer-associated cachexia in pancreatic cancer patients and (2) assess the feasibility and acceptability of diet and exercise interventions for cachexia management. The study will use retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age ≥ 18 years
- Histologically or cytologically confirmed diagnosis of pancreatic exocrine malignancy (e.g.pancreatic ductal adenocarcinoma, acinar cell carcinoma, pancreatic adenosquamous carcinoma, etc.) or clinical features highly suggestive of such malignancy with diagnostic confirmation anticipated during the screening or early study period.
- Presentation consistent with resectable, borderline resectable, local, or locally advanced, or metastatic disease
- May or may not have had surgery
- Treatment plan likely includes systemic therapy for pancreatic cancer
- ECOG performance status 0-2
- Able to tolerate oral intake and not currently receiving enteral or parenteral nutrition
- Able to read and speak English
- Able to provide written informed consent
Exclusion criteria
- Pregnant or breastfeeding at the time of enrollment
- Current use of tube feeding (enteral) or total parenteral nutrition
- Presence of ascites or other findings suggestive of decompensated disease
- Evidence or history of bowel obstruction or any gastrointestinal condition that may limit food intake
- Severe or uncontrolled psychiatric illness (e.g., psychosis, dementia) that would interfere with participation
- Presence of other uncontrolled intercurrent illnesses (e.g., infection, heart failure, liver failure) that may interfere with protocol adherence
Where it is running
1 location listed across 1 US state.
- Moffitt Cancer Center - Tampa, Florida, United States