Blood and Urine Sample Collection From Healthy Volunteers

November 29, 2021 updated by: Evotec International GmbH
The aim of the study is to obtain blood and urine samples from healthy volunteers to serve as a healthy control group for cross-cohort comparisons.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The aim of the study is to obtain peripheral venous blood samples and a urine sample from 100 healthy volunteers on one day at three different times of the day, to serve as a healthy control group for cross-cohort comparisons.

With the help of the urine and blood samples obtained in this context, a cohort of a healthy collective is to be established for further research purposes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • CTC North

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers who met all inclusion and none of the exlusion criteria

Description

Inclusion Criteria:

  • Healthy male and female subjects aged 40-70 years.
  • Caucasian
  • Non-smokers or ex-smokers
  • Body Mass Index (BMI): ≥18.5 and ≤32 kg/m2
  • Presence of a negative SARS-CoV-2 PCR test.

Exclusion Criteria:

  • Complaints that may indicate the presence of an infection, including Covid-19.
  • Pathological alcohol consumption.
  • Positive alcohol breath test at the preliminary examination.
  • Alcohol consumption within the last 24 hours before the start of sampling.
  • History of drug dependence.
  • Positive urine drug test during the preliminary examination.
  • Clinically significant acute or chronic disease. In particular, chronic inflammation, rheumatological and other autoimmune diseases, diabetes and other metabolic diseases.
  • Indications in the medical history or during the medical examination that may jeopardize the safety of the study participant by participating in the study.
  • History of relevant clinically significant cardiovascular disorders or clinically relevant hyper- or hypotension or clinically relevant brady- or tachycardia at screening as assessed by an investigator.
  • Heart rate <45/min after 5 minutes in a quiet sitting position.
  • Heart rate >100/min after 5 minutes in a quiet sitting position.
  • Systolic blood pressure of > 170 mmHg or < 90 mmHg.
  • Diastolic blood pressure of > 95 mmHg and/or < 60 mmHg.
  • Regular use of prescription medication within 3 months prior to inclusion in the research project.
  • Use of non-prescription medications within 3 days prior to inclusion in the research project.
  • Presence of clinically significant food intolerance and/or food allergy as assessed by the investigator.
  • Medically relevant previous operations.
  • Condition following radio- or chemotherapy.
  • History of oncological diseases.
  • Blood and/or plasma donation within the last 30 days prior to sample collection.
  • Pregnant or nursing female.
  • Employees of study site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Collection of blood samples from healthy volunteers to serve as a healthy control group.
Time Frame: 1 day
There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the blood samples as a control group.
1 day
Collection of urine samples from healthy volunteers to serve as a healthy control group.
Time Frame: 1 day
There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the urine samples as a control group.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Evotec International GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hanna Peradziryi, Hanna.Peradziryi@evotec.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EVT_CTC_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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