A First-in-Human Study of FID-022 in Solid Tumor Patients
NCT ID: NCT07249775
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-10-08
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Pancreatic Cancer Patients
Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.
Baseline Lifestyle and Symptom Assessment
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
Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.
Oncology Clinicians
Medical oncologists, APPs, dietitians involved in pancreatic cancer care.
Feasibility Survey
One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.
Interventions
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Baseline Lifestyle and Symptom Assessment
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
Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.
Feasibility Survey
One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC) or clinical features highly suggestive of PDAC with diagnostic confirmation anticipated during the screening or early study period.
* Presentation consistent with resectable, borderline resectable, local, or locally advanced, nonmetastatic disease
* Treatment-naive at the time of enrollment (i.e., no prior systemic therapy or radiation for pancreatic cancer)
* 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
18 Years
ALL
No
Sponsors
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Florida Cancer Innovation Fund
UNKNOWN
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Ghulam Rasool, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MCC-23812
Identifier Type: -
Identifier Source: org_study_id
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