Health TrialsbyHealthPanel

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

ConditionsPancreatic CancerCancer Cachexia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adults (≥18 years) with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC), presenting with resectable, borderline resectable, or locally advanced nonmetastatic disease. ECOG performance status 0-2. Total enrollment includes 100 newly diagnosed pancreatic cancer patients (cross-sectional), a longitudinal subset of 50 patients followed for 9 months, and 20 oncology clinicians completing feasibility surveys.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Baseline Lifestyle and Symptom Assessment

    Other intervention

    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 intervention

    Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.

  • Feasibility Survey

    Other intervention

    One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Pancreatic Cancer Patients2 interventions
Group B: Oncology Clinicians1 intervention

Trial outcomes

Primary outcomes

1

AI Model Performance

Investigators will rigorously assess model performance using clinically meaningful metrics (AUC-ROC, sensitivity, specificity, etc.) to confirm its reliability and readiness for clinical use.

Time frame
Up to 9 months
2

Survey Completion Rate

Percentage of patients completing all scheduled questionnaires.

Time frame
Up to 9 months
3

Wearable Adherence

Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks.

Time frame
Up to 9 months
4

Quality of Life Change

Mean change in FAACT total score from baseline to 9 months.

Time frame
Up to 9 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Florida Cancer Innovation Fund

Collaborator

Source ClinicalTrials.gov
Apply now