CTC in Predicting Neoadjuvant Chemotherapy Among LABC Pat... | NCT03732339

Studies
CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial

NCT03732339

Sponsor

RenJi Hospital

Status

Completed

Last Update Posted

Apr 29, 2022Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Locally Advanced 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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2018Actual

Primary Completion Date

Mar 11, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Oct 8, 2018

First Submission Date that Met QC Criteria

Nov 4, 2018

First Posted Date

Nov 6, 2018Actual

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

Apr 23, 2022

Last Update Posted Date

Apr 29, 2022Actual

Name	Class
Beijing Viroad Biotechnology Co., Ltd.	INDUSTRY

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. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.

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

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GILUPI CellCollector®	Experimental		Device: GILUPI CellCollector®

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictive value of CTC in ypT0 ypN0		Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy

Secondary Outcomes

Measure	Description	Time Frame
Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR		before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
hypersensitivity	Number of participants with hypersensitivity as assessed by CTCAE v4.0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
ECOG 0-1
Adequate organ function
Consent to undergo CTC analysis in vivo

Exclusion Criteria:

Pregnant or breastfeeding patients
Metastatic or recurrent patients
Uncontrollable 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

Not provided

Overall Officials

Name	Affiliation	Role
Jinsong Lu	RenJi Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiao Tong University		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
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided