Pancreatic CancerNCT07249775
A First-in-Human Study of FID-022 in Solid Tumor Patients
An observational study of Pancreatic Cancer and Cancer Cachexia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Cancer Cachexia
- What is being tested?
- Baseline Lifestyle and Symptom Assessment, Extended Lifestyle Monitoring and Feasibility Survey
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years) with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC), presenting with resectable, borderline resectable, or locally advanced nonmetastatic disease. ECOG performance status 0-2. Total enrollment includes 100 newly diagnosed pancreatic cancer patients (cross-sectional), a longitudinal subset of 50 patients followed for 9 months, and 20 oncology clinicians completing feasibility surveys.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Sanjukta Bhattacharjee, 813-745-0279, Sanjukta.Bhattacharjee@moffitt.org
Ghulam Rasool, PhD
About this study
Official title: AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions
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.
- Conditions
- Pancreatic Cancer, Cancer Cachexia
- Being tested
- Baseline Lifestyle and Symptom Assessment, Extended Lifestyle Monitoring, Feasibility Survey
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Lifestyle and Symptom AssessmentOther
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 MonitoringOther
Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.
Feasibility SurveyOther
One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer Patients | Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma. Receives: Other: Baseline Lifestyle and Symptom Assessment; Other: Extended Lifestyle Monitoring | |
| Oncology Clinicians | Medical oncologists, APPs, dietitians involved in pancreatic cancer care. Receives: Other: Feasibility Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI Model Performance
Investigators will rigorously assess model performance using clinically meaningful metrics (AUC-ROC, sensitivity, specificity, etc.) to confirm its reliability and readiness for clinical use.
Measured: Up to 9 months
Survey Completion Rate
Percentage of patients completing all scheduled questionnaires.
Measured: Up to 9 months
Wearable Adherence
Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks.
Measured: Up to 9 months
Quality of Life Change
Mean change in FAACT total score from baseline to 9 months.
Measured: Up to 9 months
Physical Activity Change
Mean increase in weekly moderate-to-vigorous activity minutes.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start8 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Cancer Innovation Fund
- Responsible party
- Sponsor
- Investigators
- Ghulam Rasool, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249775
- Sponsor's protocol ID
- MCC-23812
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions
- ClinicalTrials.gov ID
- NCT07249775
- Acronym / sponsor ID
- MCC-23812
- Conditions
- Pancreatic Cancer, Cancer Cachexia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Florida Cancer Innovation Fund
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer Patients | – | Other: Baseline Lifestyle and Symptom Assessment, Other: Extended Lifestyle MonitoringPatients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma. |
| Oncology Clinicians | – | Other: Feasibility SurveyMedical oncologists, APPs, dietitians involved in pancreatic cancer care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC), presenting with resectable, borderline resectable, or locally advanced nonmetastatic disease. ECOG performance status 0-2. Total enrollment includes 100 newly diagnosed pancreatic cancer patients (cross-sectional), a longitudinal subset of 50 patients followed for 9 months, and 20 oncology clinicians completing feasibility surveys.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline Lifestyle and Symptom AssessmentDietary 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. | Other | Pancreatic Cancer Patients |
| Extended Lifestyle MonitoringWearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months. | Other | Pancreatic Cancer Patients |
| Feasibility SurveyOne-time structured survey assessing integration of diet and exercise interventions into clinical workflow. | Other | Oncology Clinicians |
Primary outcome
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.
Survey Completion Rate
Time frame: Up to 9 months
Percentage of patients completing all scheduled questionnaires.
Wearable Adherence
Time frame: Up to 9 months
Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks.
Quality of Life Change
Time frame: Up to 9 months
Mean change in FAACT total score from baseline to 9 months.
Physical Activity Change
Time frame: Up to 9 months
Mean increase in weekly moderate-to-vigorous activity minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ghulam Rasool, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Cancer Cachexia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjukta Bhattacharjee (813-745-0279, Sanjukta.Bhattacharjee@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AI Model Performance (time frame: Up to 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.