A First-in-Human Study of FID-022 in Solid Tumor Patients

Recruiting now

Conditions studied: Pancreatic Cancer, Cancer Cachexia

In brief

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.

Key facts

Study ID: NCT07249775
Run by: H. Lee Moffitt Cancer Center and Research Institute
People needed: 120
Starts: 2025-10-08
Expected to finish: 2026-10-01
Last updated by the study team: 2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Moffitt Cancer Center — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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