First-in-human testing of FID-022 in solid tumor patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational effort combines retrospective records from the Florida Pancreas Collaborative with prospective enrollment of newly diagnosed pancreatic cancer patients at Moffitt Cancer Center. Researchers will validate a multimodal AI model that uses clinical, imaging, and lifestyle data to detect early cancer-associated cachexia. Enrolled participants will complete baseline lifestyle and symptom assessments, extended lifestyle monitoring, and a feasibility survey about diet and exercise interventions. The study will describe how well the AI predicts early weight and muscle loss and whether patients find the proposed nutritional and activity supports practical and acceptable.

Why it matters

Who can join: the full rules

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

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Ghulam Rasool, PhD — Moffitt Cancer Center
• Study coordinator: Sanjukta Bhattacharjee
• Email: Sanjukta.Bhattacharjee@moffitt.org
• Phone: 813-745-0279

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.