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NCT07249775Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
18 Nov 2025
Start date
8 Oct 2025
Primary completion date
Oct 2026
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
NCT number
NCT07249775

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 8 Oct 2025 to the primary completion date, Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Pregnant or breastfeeding at the time of enrollment
  • Current use of tube feeding (enteral) or total parenteral nutrition

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.