Actively Recruiting
A First-in-Human Study of FID-022 in Solid Tumor Patients
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-01-28
120
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
F
Florida Cancer Innovation Fund
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
A First-in-Human Study of FID-022 in Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �318 years
- Histologically or cytologically confirmed pancreatic exocrine malignancy or clinical features highly suggestive of such malignancy with diagnostic confirmation anticipated during screening or early study period
- Presentation consistent with resectable, borderline resectable, local, 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
You will not qualify if you...
- 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 such as psychosis or dementia that would interfere with participation
- Presence of other uncontrolled intercurrent illnesses such as infection, heart failure, or liver failure that may interfere with protocol adherence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
S
Sanjukta Bhattacharjee
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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