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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853016
• Other study ID #: AST-017
• Status: Recruiting
• Start date: March 21, 2022
• Est. completion date: May 2023

Study information

• Verified date: March 2023
• Source: Astute Medical, Inc.
• Contact: Clinical Scientist
• Phone: 314-728-1603
• Email: IA-clinical-affairs[@]biomerieux.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Healthy

Intervention

Diagnostic Test:
• Urine collection for NEPHROCLEAR CCL14 Test
Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test

Locations

Country	Name	City	State
United States	Cyn3rgy Research	Gresham	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Astute Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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