NCT07249775

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

AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

• Pancreatic Cancer
• Cancer Cachexia

Interventions

Type	Name	Description
OTHER	Baseline Lifestyle and Symptom Assessment	Dietary questionnaire (VioScreen), symptom and QoL surveys (ESAS-r, FAACT, PROMIS PF, PG-SGA), physical activity survey (Modified GLTEQ), functional fitness tests, DEXA scans, blood draws.
OTHER	Extended Lifestyle Monitoring	Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.
OTHER	Feasibility Survey	One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.

Timeline

• Start date: 2025-10-08
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-11-25
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States