A First-in-Human Study of FID-022 in Solid Tumor Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baseline Lifestyle and Symptom Assessment, Extended Lifestyle Monitoring, Feasibility Survey.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Cancer Cachexia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions
Overview
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]
- Survey Completion Rate [Time frame: Up to 9 months]
- Wearable Adherence [Time frame: Up to 9 months]
- Quality of Life Change [Time frame: Up to 9 months]
- Physical Activity Change [Time frame: Up to 9 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Identifiers
NCT: NCT07249775 · MCC-23812