TumorsNCT04977739
Research on the Application and Mechanism of New Biological Probes in Biomedicine
An observational study of Tumors and Cardiovascular Diseases, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumors, Cardiovascular Diseases, Respiratory System Diseases
- How many people
- 737 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2021to 25 Jul 2022
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NanFang Hospital samples
Who may be able to join
- Sign the informed consent form voluntarily.
- Age 18-70 years old.
- High expression (positive) group: The results of multiple laboratory tests indicate that the marker is higher than the normal range.
- Low expression (negative) healthy volunteer group: those with no underlying diseases and no abnormalities in the physical examination.
- Have routine examination to check the remaining body fluid samples, and the body fluid samples are not contaminated.
Who cannot join
- Accompanied by other inflammations.
- The data of the subject is not complete, or the collection of cases is incomplete due to other reasons.
- The researcher judged that it was not suitable to participate in this research.
Trial locations and contacts
1 site in 1 country.
About this study
Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Aggregation-Caused Quenching has limited the application of traditional fluorescent probes to some extent. This project intends to systematically evaluate the detection efficiency of new methods through the detection of biomarkers in clinical samples and the comparison with the detection methods of traditional biomarkers, so as to provide theoretical and experimental basis for the establishment of fast and simple biomarker detection technologies with new biological probes.
- Conditions
- Tumors, Cardiovascular Diseases, Respiratory System Diseases, Digestive System Diseases, Endocrine System Diseases, Metabolic Diseases
- Being tested
- No intervention
- Medical subject headings
- Neoplasms, Cardiovascular Diseases, Respiratory Tract Diseases, Digestive System Diseases, Endocrine System Diseases, Metabolic Diseases, Immune System Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| those with a condition | Not described Receives: Diagnostic Test: No intervention | |
| those without a condition | Not described Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
signal intensity of the probes
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start3 Aug 2021
- Primary completion15 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bo Situ, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977739
- Sponsor's protocol ID
- NFEC-2021-007
- Status last verified
- Jun 2021
- First submitted
- 14 Jul 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application and Mechanism of New Biological Probes in Biomedicine
- ClinicalTrials.gov ID
- NCT04977739
- Acronym / sponsor ID
- NFEC-2021-007
- Conditions
- Tumors, Cardiovascular Diseases, Respiratory System Diseases, Digestive System Diseases, Endocrine System Diseases, Metabolic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 27 Jul 2021 (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.
Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Aggregation-Caused Quenching has limited the application of traditional fluorescent probes to some extent. This project intends to systematically evaluate the detection efficiency of new methods through the detection of biomarkers in clinical samples and the comparison with the detection methods of traditional biomarkers, so as to provide theoretical and experimental basis for the establishment of fast and simple biomarker detection technologies with new biological probes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| those with a condition | – | Diagnostic Test: No intervention |
| those without a condition | – | Diagnostic Test: No intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NanFang Hospital samples
Key inclusion criteria (5 listed)
- Sign the informed consent form voluntarily.
- Age 18-70 years old.
- High expression (positive) group: The results of multiple laboratory tests indicate that the marker is higher than the normal range.
- Low expression (negative) healthy volunteer group: those with no underlying diseases and no abnormalities in the physical examination.
- Have routine examination to check the remaining body fluid samples, and the body fluid samples are not contaminated.
Key exclusion criteria (3 listed)
- Accompanied by other inflammations.
- The data of the subject is not complete, or the collection of cases is incomplete due to other reasons.
- The researcher judged that it was not suitable to participate in this research.
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 |
|---|---|---|
| No interventionNo intervention | Diagnostic test | those with a condition, those without a condition |
Primary outcome
signal intensity of the probes
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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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.
Bo Situ study director
Nanfang Hospital, Southern Medical University
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 Tumors and Cardiovascular Diseases, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 22 Aug 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
signal intensity of the probes (time frame: one day). 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 22 Aug 2022.