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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Chronic Disease
• Intervention / Treatment: Diagnostic test: Urine collection for NEPHROCLEAR CCL14 Test

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Clinical Scientist; Phone Number: 314-728-1603; Email: IA-clinical-affairs@biomerieux.com

Study Locations

• United States
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Recruiting
      • Cyn3rgy Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Apparently Healthy Adults and Adults With Chronic, Stable Morbidities

Description

Cohort A

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Healthy adults	Diagnostic test: Urine collection for NEPHROCLEAR CCL14 Test; Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test
Cohort B; Adults with stable chronic morbidities	Diagnostic test: Urine collection for NEPHROCLEAR CCL14 Test; Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astute Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: AST-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes