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

NCT07249775 | Recruiting

• 1 other identifier: MCC-23812
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Pancreatic Cancer; Cancer Cachexia

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to 9 months

• Survey Completion Rate

  Percentage of patients completing all scheduled questionnaires.

  Up to 9 months

• Wearable Adherence

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

  Up to 9 months

• Quality of Life Change

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

  Up to 9 months

• Physical Activity Change

  Mean increase in weekly moderate-to-vigorous activity minutes.

  Up to 9 months

Study Arms (2)

Pancreatic Cancer Patients

Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.

Other: Baseline Lifestyle and Symptom Assessment; Other: Extended Lifestyle Monitoring

Oncology Clinicians

Medical oncologists, APPs, dietitians involved in pancreatic cancer care.

Other: Feasibility Survey

Interventions

Baseline Lifestyle and Symptom Assessment OTHER

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.

Pancreatic Cancer Patients

Extended Lifestyle Monitoring OTHER

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

Pancreatic Cancer Patients

Feasibility Survey OTHER

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

Oncology Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Florida Cancer Innovation Fund: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ghulam Rasool, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjukta Bhattacharjee

CONTACT

813-745-0279; Sanjukta.Bhattacharjee@moffitt.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)