HealthyNCT05853016
A Urine Sample Collection Study in Apparently Healthy Adults and Adults With Chronic, Stable Morbidities
An observational study of Healthy and Chronic Disease, run by Astute Medical, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Disease
- What is being tested?
- Urine collection for NEPHROCLEAR CCL14 Test
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparently Healthy Adults and Adults With Chronic, Stable Morbidities
Who may be able to join
- Apparently healthy adults (age > 21 years);
- Provide written informed consent for study participation.
- Adults (age > 21 years);
- One or more of the following chronic, stable morbid conditions:
- 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.
Who cannot join
- Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
- Any known or suspected significant new onset or chronic morbid medical condition such as those listed in the inclusion criteria for Cohort B;
- 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;
Show all 17Show fewer
- Prisoners or institutionalized individuals;
- Already provided a urine sample for this study.
- Cohort B
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cyn3rgy Research
Gresham, Oregon, 97030
About this study
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
- Being tested
- Urine collection for NEPHROCLEAR CCL14 Test
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collection for NEPHROCLEAR CCL14 TestDiagnostic test
Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Healthy adults Receives: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test | |
| Cohort B | Adults with stable chronic morbidities Receives: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Determined for urine sample collected at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start21 Mar 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astute Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853016
- Sponsor's protocol ID
- AST-017
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Urine Sample Collection Study in Apparently Healthy Adults and Adults With Chronic, Stable Morbidities
- ClinicalTrials.gov ID
- NCT05853016
- Acronym / sponsor ID
- AST-017
- Conditions
- Healthy, Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Astute Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 TestHealthy adults |
| Cohort B | – | Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 TestAdults with stable chronic morbidities |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparently Healthy Adults and Adults With Chronic, Stable Morbidities
Key inclusion criteria (5 listed)
- Apparently healthy adults (age > 21 years);
- Provide written informed consent for study participation.
- Adults (age > 21 years);
- One or more of the following chronic, stable morbid conditions:
- 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.
Key exclusion criteria (17 listed)
- Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
- Any known or suspected significant new onset or chronic morbid medical condition such as those listed in the inclusion criteria for Cohort B;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine collection for NEPHROCLEAR CCL14 TestUrine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test | Diagnostic test | Cohort A, Cohort B |
Primary outcome
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
Time frame: Determined for urine sample collected at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Chronic Disease, run by Astute Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Scientist (314-728-1603, IA-clinical-affairs@biomerieux.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Determined for urine sample collected at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.