CTCs in Breast Cancer After Neoadjuvant Treatment and Sur... | NCT05360290

Studies
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial

NCT05360290

Sponsor

RenJi Hospital

Status

Recruiting

Last Update Posted

Feb 3, 2026Actual

Enrollment

484Estimated

Phase

Not Applicable

Conditions

Breast Cancer
Circulating Tumor Cell

Interventions

GILUPI CellCollector®

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

Feb 2026

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

Sep 14, 2022Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2029Estimated

First Submitted Date

Apr 23, 2022

First Submission Date that Met QC Criteria

Apr 29, 2022

First Posted Date

May 4, 2022Actual

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

Feb 1, 2026

Last Update Posted Date

Feb 3, 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

The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

484Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTC positive	Active Comparator		Device: GILUPI CellCollector®
CTC negative	Other		Device: GILUPI CellCollector®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GILUPI CellCollector®	Device	Use of GILUPI CellCollector® to detect CTC	CTC negative CTC positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
invasive disease-free survival (iDFS)	Invasive disease-free survival time is defined as the time from date of randomization until the first occurrence of invasive disease recurrence, distant metastasis and death from any cause.	From surgery until time of event up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
pathological complete response (pCR)	ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is	at surgery
overall Survival (OS)	Overall survival is defined as the time from randomization to death from any cause.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, aged ≥18 and ≤70 years;
Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment);
Completed neoadjuvant treamtment and surgery (within 4 years after surgery);
Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen);
ECOG 0-1

Exclusion Criteria:

Metastatic disease (Stage IV);
Female patients who are pregnancy or lactation;
Uncontrollable puncture site infection or systemic infection;

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenji Yin	Contact	86(21)68385569		followroad@163.com
Qi Lu	Contact	86(21)68383364		rjllb3364@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Recruiting	Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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
D009360	Neoplastic Cells, Circulating

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided