NCT07249775 · H. Lee Moffitt Cancer Center and Research Institute
A First-in-Human Study of FID-022 in Solid Tumor Patients
What this study 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.
View original scientific description
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.
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.
Primary outcome measures
AI Model Performance
Time frame: Up to 9 months
Investigators will rigorously assess model performance using clinically meaningful metrics (AUC-ROC, sensitivity, specificity, etc.) to confirm its reliability and readiness for clinical use.
Survey Completion Rate
Time frame: Up to 9 months
Percentage of patients completing all scheduled questionnaires.
Wearable Adherence
Time frame: Up to 9 months
Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks.
Quality of Life Change
Time frame: Up to 9 months
Mean change in FAACT total score from baseline to 9 months.
Physical Activity Change
Time frame: Up to 9 months
Mean increase in weekly moderate-to-vigorous activity minutes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Tampa, Florida
Collaborators
Florida Cancer Innovation Fund
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations