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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07249775
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baseline Lifestyle and Symptom Assessment — OTHER
    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.
  • Extended Lifestyle Monitoring — OTHER
    Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.
  • Feasibility Survey — OTHER
    One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.

Study Details

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 Dates

Start date
Oct 8, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Pancreatic Cancer Patients
    Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.
  • Arm: Oncology Clinicians
    Medical oncologists, APPs, dietitians involved in pancreatic cancer care.

Primary Outcome Measure

AI Model Performance [ Time Frame: Up to 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Sanjukta Bhattacharjee
[email protected]
813-745-0279
Ghulam Rasool, PhD (PRINCIPAL_INVESTIGATOR)
Sylvia Crowder, PhD (PRINCIPAL_INVESTIGATOR)
Nathan Parker, PhD (PRINCIPAL_INVESTIGATOR)
Jennifer Permuth, PhD (PRINCIPAL_INVESTIGATOR)
Matthew Schabath, PhD (SUB_INVESTIGATOR)
Alia Qayyum, MD (SUB_INVESTIGATOR)
Brian Gonzalez, PhD (SUB_INVESTIGATOR)
Daniel Jeong, MD (SUB_INVESTIGATOR)
Dae Won Kim, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Moffitt Cancer Center· Tampa, FL

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