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

January 26, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Matthew Schabath, PhD
        • Sub-Investigator:
          • Dae Won Kim, MD
        • Principal Investigator:
          • Sylvia Crowder, PhD
        • Sub-Investigator:
          • Brian Gonzalez, PhD
        • Principal Investigator:
          • Nathan Parker, PhD
        • Principal Investigator:
          • Jennifer Permuth, PhD
        • Contact:
        • Principal Investigator:
          • Ghulam Rasool, PhD
        • Sub-Investigator:
          • Alia Qayyum, MD
        • Sub-Investigator:
          • Daniel Jeong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreatic Cancer Patients
Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.
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.
Oncology Clinicians
Medical oncologists, APPs, dietitians involved in pancreatic cancer care.
Other: Feasibility Survey
One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 9 months
Survey Completion Rate
Time Frame: Up to 9 months
Percentage of patients completing all scheduled questionnaires.
Up to 9 months
Wearable Adherence
Time Frame: Up to 9 months
Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks.
Up to 9 months
Quality of Life Change
Time Frame: Up to 9 months
Mean change in FAACT total score from baseline to 9 months.
Up to 9 months
Physical Activity Change
Time Frame: Up to 9 months
Mean increase in weekly moderate-to-vigorous activity minutes.
Up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Florida Cancer Innovation Fund

Investigators

  • Principal Investigator: Ghulam Rasool, PhD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23812

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Baseline Lifestyle and Symptom Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe