Breast CancerNCT06529614
An In-situ Detection for MicroRNA
An observational study of Breast Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
We designed a new in-site detection method for MicroRNA in the serum of patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- In-situ detection for Micro-RNA
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to 1 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who have diagnosed with breat cancer
Who may be able to join
- -
Who cannot join
- situations that may affect the results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Lei Dou, Dr., 15171473498, 616732045@qq.com
About this study
Official title: A New Detection Method for MicroRNA in Patients With Breast Cancer
We designed a new in-site detection method for MicroRNA in the serum of patients with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- In-situ detection for Micro-RNA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-situ detection for Micro-RNAOther
a new in-situ detection methods for Micro-RNA
| Study group | Role | What they receive |
|---|---|---|
| Health donor group | Not described Receives: Other: In-situ detection for Micro-RNA | |
| Breast cancer group | Not described Receives: Other: In-situ detection for Micro-RNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of test
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start20 Jul 2024
- Primary completion1 Sep 2025
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Dou, Tongji Hospital
- Investigators
- Shabei Xu, Dr., Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529614
- Sponsor's protocol ID
- 20240771
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Detection Method for MicroRNA in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06529614
- Acronym / sponsor ID
- 20240771
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 31 Jul 2024 (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.
We designed a new in-site detection method for MicroRNA in the serum of patients with breast cancer.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health donor group | – | Other: In-situ detection for Micro-RNA |
| Breast cancer group | – | Other: In-situ detection for Micro-RNA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who have diagnosed with breat cancer
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- situations that may affect the results
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 |
|---|---|---|
| In-situ detection for Micro-RNAa new in-situ detection methods for Micro-RNA | Other | Breast cancer group, Health donor group |
Primary outcome
Sensitivity and specificity of test
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Shabei Xu, Dr. study director
Tongji Hospital
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 Breast Cancer, run by Tongji Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Dou, Dr. (15171473498, 616732045@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of test (time frame: 8 months). 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 6 Oct 2025.