The Association of Lunula Status With the Efficacy and Sa... | NCT07590570

Studies
The Association of Lunula Status With the Efficacy and Safety of Neoadjuvant Therapy in Breast Cancer

NCT07590570

Sponsor

Wenjin Yin

Status

Active, not recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

188Estimated

Phase

Not provided

Conditions

Breast Cancer Invasive

Interventions

neoadjuvant therapy

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

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2026Actual

Primary Completion Date

Jan 2031Estimated

Completion Date

Jan 2033Estimated

First Submitted Date

May 10, 2026

First Submission Date that Met QC Criteria

May 10, 2026

First Posted Date

May 15, 2026Actual

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

May 10, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multicentre study to investigate the association of fingernail lunula status with the efficacy and safety of neoadjuvant therapy in breast cancer patients.

Detailed Description

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

188Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
retrospective		no requirements for therapy	Drug: neoadjuvant therapy
prospective		no requirements for therapy	Drug: neoadjuvant therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neoadjuvant therapy	Drug	patients receiving neoadjuvant therapy	prospective retrospective

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathological Complete Response (pCR) Rate	ypT0 ypN0	at surgery

Secondary Outcomes

Measure	Description	Time Frame
Disease-free Survival	Disease-free survival time is defined as the time from date of randomization until the first occurrence of disease recurrence, distant metastasis and death from any cause.	From surgery until time of event up to 8 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
Pathologically confirmed invasive primary breast cancer
Patients who have received or are scheduled to receive neoadjuvant therapy

Exclusion Criteria:

De novo stage IV breast cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients who have received or plan to receive neoadjuvant therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wenjin Yin	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiaotong University		Shanghai		200127	China

Intervention Browse Module

MeSH Terms

ID	Term
D020360	Neoadjuvant Therapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided