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

NCT07249775 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-01-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Florida Cancer Innovation Fund

    collaborator UNKNOWN

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Ghulam Rasool, PhD · Moffitt Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07249775 on ClinicalTrials.gov