Clincosm LogoSign in Get a demo

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

Sponsor
Astute Medical, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05853016
Collaborator
(none)
600
Enrollment
1
Location
13.3
Anticipated Duration (Months)
45
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Urine Sample Collection Study in Apparently Healthy Adults and Adults With Chronic, Stable Morbidities
Actual Study Start Date :
Mar 21, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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:

  1. Active cancer ii. Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia)
  1. 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)
  2. Polycystic kidney disease xx. Rheumatoid arthritis xxi. Systemic Lupus Erythematosus
  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cyn3rgy Research Gresham Oregon United States 97030

Sponsors and Collaborators

  • Astute Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Astute Medical, Inc.
ClinicalTrials.gov Identifier:
NCT05853016
Other Study ID Numbers:
  • AST-017
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Chronic Disease

Study Results

No Results Posted as of May 10, 2023