NCT07249775 A First-in-Human Study of FID-022 in Solid Tumor Patients
| NCT ID | NCT07249775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-10-08 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ghulam Rasool, PhD
PRINCIPAL INVESTIGATOR
Moffitt Cancer Center
Frequently Asked Questions
Who can join the NCT07249775 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07249775 currently recruiting?
Yes, NCT07249775 is actively recruiting participants. Contact the research team at Sanjukta.Bhattacharjee@moffitt.org for enrollment information.
Where is the NCT07249775 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT07249775 clinical trial?
NCT07249775 is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The principal investigator is Ghulam Rasool, PhD at Moffitt Cancer Center. The trial plans to enroll 120 participants.
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