Performance Evaluation Study of the reagent Total Bile Acids FS in humane stool samples
Organizational Data
- DRKS-ID:
- DRKS00031283
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2023-02-24
- Last update in DRKS:
- 2023-11-29
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
For this retrospective study, stool samples were processed by the clinic/laboratory using a tube approved for this purpose. These samples are provided pseudonymously within the framework of existing contracts. The components of the stool sample are measured at DiaSys against set calibrators and controls in a run of clinical chemistry analyzers. After validation of the measurement and statistical evaluation of the data, the obtained data will be prepared for publication.
Health condition or problem studied
- ICD10:
- K50 - Crohn disease [regional enteritis]
- ICD10:
- K58 - Irritable bowel syndrome
- ICD10:
- K90 - Intestinal malabsorption
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- In this monocentric, retrospective performance evaluation study, processed stool samples with the Total Bile Acids 21 FS reagent kit will be evaluated on the clinical chemistry analyzer platforms (BioMajesty® JCA-BM6010/C, respons®910, respons®940) and in particular the comparability of the DiaSys test will be demonstrated. Some samples quantified by LC-MS/MS will be used as reference. For the planned study, performance comparisons in accordance with EP protocols (e.g. control recovery, precision, LOB, correlation, method comparisons, linearity) between the different instruments will be included.
- Arm 2:
- Normal patients and patients around the cut-off as comparison samples. The evaluation will be determined in reference to an ELISA-based TBA stool test.
Endpoints
- Primary outcome:
- Quantitative measurements through the Total Bile Acids FS reagent on clinical chemistry analyzers and determination of the recovery and the accuracy against LC-MS/MS referenced liquid individual Bile Acids Standards
- Secondary outcome:
- not defined
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- Retrospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other biovis Diagnostik MVZ GmbH Limburg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2023-02-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-08-01
- Target Sample Size:
- 200
- Final Sample Size:
- 200
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- Physician's request to determine bile acids in stool
Exclusion Criteria
Hospitalization
Addresses
Primary Sponsor
- Address:
- DiaSys Diagnostic Systems GmbH65558 HolzheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- DiaSys Diagnostic Systems GmbHProf. Dr. Matthias GrimmlerAlte Straße 965558 HolzheimGermany
- Telephone:
- +49 6432 9146 486
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- DiaSys Diagnostic Systems GmbHProf. Dr. Matthias GrimmlerAlte Straße 965558 HolzheimGermany
- Telephone:
- +49 6432 9146 486
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- DiaSys Diagnostic Systems GmbHProf. Dr. Matthias GrimmlerAlte Straße 965558 HolzheimGermany
- Telephone:
- +49 6432 9146 486
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- DiaSys Diagnostic Systems GmbHAlte Straße 965558 HolzheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzDeutschhausplatz 355116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-11-30
- Ethics committee number:
- 2022-16840-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-01-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry