An In-situ Detection for MicroRNA | NCT06529614

Studies
An In-situ Detection for MicroRNA

NCT06529614

Sponsor

Tongji Hospital

Status

Recruiting

Last Update Posted

Oct 6, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

In-situ detection for Micro-RNA

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2024Actual

Primary Completion Date

Sep 1, 2025Actual

Completion Date

Nov 1, 2025Estimated

First Submitted Date

Jul 26, 2024

First Submission Date that Met QC Criteria

Jul 26, 2024

First Posted Date

Jul 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2025

Last Update Posted Date

Oct 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health donor group			Other: In-situ detection for Micro-RNA
Breast cancer group			Other: In-situ detection for Micro-RNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
In-situ detection for Micro-RNA	Other	a new in-situ detection methods for Micro-RNA	Breast cancer group Health donor group

Measure	Description	Time Frame
Sensitivity and specificity of test		8 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Healthy without serious diseases

Exclusion Criteria:

situations that may affect the results

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

The patients who have diagnosed with breat cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Dou, Dr.	Contact	15171473498		616732045@qq.com

Overall Officials

Name	Affiliation	Role
Shabei Xu, Dr.	Tongji Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital	Recruiting	Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035683	MicroRNAs

Ancestor Terms

ID	Term
D016372	RNA, Antisense
D016375	Antisense Elements (Genetics)
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012313	RNA

Browse Leaves

Not provided

Browse Branches

Not provided