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

NCT05853016 | Unknown FDA Device

• 1 other identifier: AST-017
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort A

Healthy adults

Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Cohort B

Adults with stable chronic morbidities

Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Interventions

Urine collection for NEPHROCLEAR CCL14 Test DIAGNOSTIC_TEST

Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test

Cohort A; Cohort B

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Apparently Healthy Adults and Adults With Chronic, Stable Morbidities

You may qualify if:

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

You may not qualify if:

• Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
• Trauma-related surgery within the last 6 months;
• Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
• Received any blood product transfusion within the previous 2 months;
• Pregnant women or children;
• Prisoners or institutionalized individuals;
• Already provided a urine sample for this study.
• Cohort B
• Adults (age \> 21 years);
• 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.
• Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
• Any new onset or unstable morbidities;
• Trauma-related surgery within the last 6 months;
• Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;

Sponsors & Collaborators

• Astute Medical, Inc.: lead

Study Sites (1)

Cyn3rgy Research

Gresham, Oregon, 97030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Chronic Disease

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Clinical Scientist

CONTACT

314-728-1603; IA-clinical-affairs@biomerieux.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: May 10, 2023
• Study Start: March 21, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)