An observational study in Carrier State, Pancreatic Disease and Kidney Diseases, sponsored by Philip Polgreen. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Philip Polgreen · Observational
Among 60 studies in Pancreatic Diseases with a site in United States — 13 open to participants now, 15 under way, 1 of them phase 3. Pancreatic Diseases · United States.
Among the 60 studies in Pancreatic Diseases with a site in United States, this one is the 5th largest by planned enrollment of the 18 observational ones, is one of 4 that started in 2021, is one of 18 observational ones, reaches primary completion later than 3 of the 14 other live ones, and was the 50th registered.
184 studies on the registry are indexed under Pancreatic Diseases; 63 are open to participants now.
This study's planned enrollment of 1,250 is above the median of 363 across 76 observational studies indexed under Pancreatic Diseases.
Browse Pancreatic Diseases studies →13 of the 60 studies in Pancreatic Diseases with a site in United States are open now, in 9 countries. Each count lists the studies.
Of the 43 Pancreatic Diseases studies recruiting now, 25 (58%) set no upper age limit and 4 (9%) stop at 75 or younger; 7 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 4 started in 2021.
Median enrollment 76 across the 42 interventional studies, 287 across the 18 observational. Of the 36 that completed or were terminated, 21 (58%) have results posted.
17 of 60 have an industry lead sponsor. The 10 most frequent:
Philip Polgreen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Philip Polgreen has 1 study filed under Pancreatic Diseases — fewer than ten, so there is no comparison to draw.
7 of the studies in Pancreatic Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05474417Philip PolgreenThe Effects of the CF Carrier State on the Kidneys and Pancreas | 2026-12 |
| NCT06564571Orlando Health, Inc.Artificial Intelligence in Endoscopic Ultrasound | 2026-12 |
| NCT07030348Do Hyun ParkEarly Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study | 2026-12-31 |
| NCT05603702Indiana UniversitySTTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis | 2027-03-31 |
| NCT07776353Kaiser PermanenteUnderstanding New Cachexia Subtypes Through Observational Epidemiological Research | 2027-05 |
Among the 60 studies in Pancreatic Diseases with a site in United States, from their registry updates:
The overarching hypothesis is that CF carriers are at increased risk for developing most of the extrapulmonary conditions associated with CF compared to the general population. Specifically, it is hypothesized that this pilot data will detect subclinical evidence of pancreatic and kidney disorders among CF carriers. This will be determined by bringing CF carriers and controls to the CRU for one visit where they will answer survey questions and undergo laboratory testing. Additionally, they will collect urine and stool samples at home that will be sent to outside laboratories for testing.
There are 2 main study components- a clinic visit (all participants) and at-home specimen collections (volunteer subsample only). Each procedure is described below.
Clinic Visit Procedures (all participants):
Height- Height will be measured to the nearest 0.5 cm. Shoes should be removed.
Weight- Weight will be measured to the nearest 0.5 kg. Shoes and any extra jackets/sweaters/layers should be removed.
Blood Pressure- Blood pressure will be measured using the following procedures- Make sure that the participant hasn't smoked for 20 minutes prior to the BP measurement. Remove all clothing that covers the location of the cuff placement. Have the participant sit comfortably in a chair, with back supported, legs uncrossed and feet flat on the floor, arm supported at the level of the heart on a table, palm facing upward. Be sure to choose a cuff that correctly fits the participant's arm size. The lower end of the cuff should be ½ to 1 inch above the inner side of the elbow joint. The middle of the cuff should be at the level of the right atrium. Place the cuff snugly around the bare upper arm so that you can only insert one finger between the cuff and the arm.
Blood Draws/2-Hour OGTT- The participant should be active and eat a regular diet for three days prior to the test. They should be instructed not to eat or drink anything except water for at least 8 hours before the test. Someone trained in phlebotomy will insert an IV into the patient's arm so that blood draws can occur before and after the oral glucose tolerance test (OGTT). They will draw 2 tubes of blood (one 3 ml lavender top tube for HbA1C and one 4.5 ml green plasma separator tube for glucose, insulin, c-peptide, and lipid values). Then, a team member will provide the participant with a chilled Fisherbrand Glucose Tolerance Test Beverage (10 oz beverage, 75 g concentration) to drink. The participant must drink the entire beverage within 5 minutes. The patient should remain seated during the 2-hours of the test. They should not eat or drink anything except for plain water during the test (no mints, cough drops, chewing gum, or smoking).
At the 1-hour mark, 1 tube of blood (4.5 ml green plasma separator tube for glucose and insulin values) will be drawn.
Once the 2 hours have passed, 2 more tubes of blood (one 3 ml lavender top tube for c-reactive protein, calprotectin, and lactoferrin and one 4.5 ml green plasma separator tube for glucose and insulin values) will be drawn.
During the downtime between blood draws, the participant will answer the questions from the baseline survey and report their current medications interview-style with the research team member.
This visit is expected to last 3-4 hours.
Home Specimen Collection (volunteer subsample only; volunteers may do urine and/or stool samples):
Participants will be given specimen collection containers and instructions on collecting the 24-hour urine sample and/or stool sample, whichever they volunteer to collect. Finally, a date, time, and meeting location will be scheduled to return the samples to the research team.
CF Carriers and Controls who are not CF carriers.
CF Carrier Inclusion Criteria:
Control Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who have been identified as Cystic Fibrosis Carriers via previous genetic testing.
Participants who have been identified as not being Cystic Fibrosis Carriers via previous genetic testing.
Comparison of Glucose Values
Comparison of glucose values in cystic fibrosis carrier group vs control group via t-tests.
Time frame: At baseline
Comparison of Insulin Values
Comparison of insulin values in cystic fibrosis carrier group vs control group via t-tests.
Time frame: At baseline
Comparison of C-Reactive Protein Values
Comparison of c-reactive protein values in cystic fibrosis carrier group vs control group via t-tests.
Time frame: At baseline
Comparison of Lactoferrin Values
Comparison of lactoferrin values in cystic fibrosis carrier group vs control group via t-tests.
Time frame: At baseline
Comparison of Calprotectin Values
Comparison of calprotectin values in cystic fibrosis carrier group vs control group via t-tests.
Time frame: At baseline
Comparison of Lipid Values
Comparison of lipid values in cystic fibrosis carrier group vs control group via t-tests.
Time frame: At baseline
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Dec 2026, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
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