A Urine Sample Collection Study in Apparently Healthy Adults and Adults With Chronic, Stable Morbidities

Recruiting

• Conditions: Chronic Disease; Healthy
• Interventions: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

• Registration Number: NCT05853016
• Lead Sponsor: Astute Medical, Inc.

Brief Summary

The objective of this study is collect urine samples from healthy adult subjects and subjects with stable chronic morbidities for future testing to serve as controls and establish reference ranges in the development of new invitro diagnostic devices.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-21
• Status Verified: 2023-03
• Study First Submitted: 2023-03-09
• Primary Completion: 2023-05
• Study Completion: 2023-05
• Study First Submitted QC: 2023-05-01
• Last Update Submitted: 2023-05-01
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Apparently healthy adults (age > 21 years);
2. Provide written informed consent for study participation.

Exclusion Criteria

1. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
2. Any known or suspected significant new onset or chronic morbid medical condition such as those listed in the inclusion criteria for Cohort B;
3. Trauma-related surgery within the last 6 months;
4. Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
5. Received any blood product transfusion within the previous 2 months;
6. Pregnant women or children;
7. Prisoners or institutionalized individuals;
8. Already provided a urine sample for this study.

Cohort B

Inclusion Criteria:

1. Adults (age > 21 years);
2. One or more of the following chronic, stable morbid conditions:

i. Active cancer ii. Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) iii. Chronic coagulation abnormality iv. Chronic obstructive pulmonary disease (including emphysema, chronic bronchitis, and asthma) v. Chronic pancreatitis vi. Chronic renal insufficiency vii. Congestive heart failure viii. Coronary artery disease ix. Diabetes mellitus (Type 1 or Type 2) x. Gout xi. Hyper- or hypothyroidism xii. Hyperlipidemia (includes hypercholesterolemia) xiii. Hypertension xiv. Immunocompromised xv. Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) xvi. Liver cirrhosis xvii. Neuromuscular disease xviii. Peripheral vascular disease (a.k.a. peripheral artery disease) xix. Polycystic kidney disease xx. Rheumatoid arthritis xxi. Systemic Lupus Erythematosus c. Provide written informed consent for study participation.

Exclusion Criteria:

1. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
2. Any new onset or unstable morbidities;
3. Trauma-related surgery within the last 6 months;
4. Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
5. Received any blood product transfusion within the previous 2 months;
6. Pregnant women or children;
7. Prisoners or institutionalized individuals;
8. Already provided a urine sample for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	Urine collection for NEPHROCLEAR CCL14 Test	Adults with stable chronic morbidities
Cohort A	Urine collection for NEPHROCLEAR CCL14 Test	Healthy adults

Primary Outcome Measures

Name	Time	Method
Reference interval as defined by Clinical and Laboratory Standards Institute guideline EP28 for urinary C-C motif chemokine 14 concentration measured with the NEPHROCLEAR CCL14 Test within each cohort	Determined for urine sample collected at baseline

Trial Locations

Locations (1)

Cyn3rgy Research; 🇺🇸 Gresham, Oregon, United States