Status:
RECRUITING
A First-in-Human Study of FID-022 in Solid Tumor Patients
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Florida Cancer Innovation Fund
Conditions:
Pancreatic Cancer
Cancer Cachexia
Eligibility:
All Genders
18+ years
Brief Summary
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 feasibi...
Eligibility Criteria
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
Key Trial Info
Start Date :
October 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07249775
Start Date
October 8 2025
End Date
October 1 2026
Last Update
January 28 2026
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612