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NCT Number: NCT07249775

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

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.

Recruiting

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Key information

Conditions

Pancreatic Cancer Cancer Cachexia Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Alia Qayyum, MD

SUB_INVESTIGATOR

Brian Gonzalez, PhD

SUB_INVESTIGATOR

Dae Won Kim, MD

SUB_INVESTIGATOR

Daniel Jeong, MD

SUB_INVESTIGATOR

Ghulam Rasool, PhD

PRINCIPAL_INVESTIGATOR

Jennifer Permuth, PhD

PRINCIPAL_INVESTIGATOR

Matthew Schabath, PhD

SUB_INVESTIGATOR

Nathan Parker, PhD

PRINCIPAL_INVESTIGATOR

Sanjukta Bhattacharjee

CONTACT

[email protected]

813-745-0279

Sylvia Crowder, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Extended Lifestyle Monitoring

Other

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

Feasibility Survey

Other

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

Primary outcomes

  1. 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.

  2. Survey Completion Rate

    Time frame: Up to 9 months

    Percentage of patients completing all scheduled questionnaires.

  3. Wearable Adherence

    Time frame: Up to 9 months

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

  4. Quality of Life Change

    Time frame: Up to 9 months

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

  5. Physical Activity Change

    Time frame: Up to 9 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjukta Bhattacharjee

CONTACT

[email protected]

813-745-0279

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Cancer Innovation Fund

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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