Clinical Study of Glycosylated Extracellular Vesicles for... | NCT05417048

Studies
Clinical Study of Glycosylated Extracellular Vesicles for Early Diagnosis of Breast Cancer

NCT05417048

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Feb 23, 2023Actual

Enrollment

420Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Blood Sample

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2022Actual

Primary Completion Date

Dec 15, 2023Estimated

Completion Date

Jun 15, 2024Estimated

First Submitted Date

Jun 6, 2022

First Submission Date that Met QC Criteria

Jun 9, 2022

First Posted Date

Jun 14, 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 22, 2023

Last Update Posted Date

Feb 23, 2023Actual

Name	Class
Beijing Glyexo Gene Technology Co., Ltd.	UNKNOWN

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, single-center, non-randomized, cohort study designed to evaluate the clinical diagnostic performance of glycosylated extracellular vesicles and their contents for early detection of breast cancer.

Detailed Description

Early screening technology can improve the survival rate of breast cancer patients. Traditional mammography and ultrasonography have limitations on performance in clinical practice. Extracellular vesicles, one of the three major resources of liquid biopsy, contain multi-omics information that can be used to discover effective biomarkers for early diagnosis and screening of cancers.

In this study, we are going to isolate glycosylated extracellular vesicles from serum of cancer patients and non-cancer people with the novel GlyExo-Capture technology, and perform miRNA sequencing to selected out breast cancer-related markers. Then an early diagnosis model of breast cancer based on the GlyExo-Capture platform is able to be established using machine learning techniques and validated by qPCR experiments.

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

Retention

Enrollment

420Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Breat cancer	Histologically confirmed breast cancer patients(Stage I-III)	Diagnostic Test: Blood Sample
Benign breast disease	Histologically confirmed breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst etc	Diagnostic Test: Blood Sample
Healthy control	No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)	Diagnostic Test: Blood Sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Sample	Diagnostic Test	Up to 5mL of blood via venipuncture	Benign breast disease Breat cancer Healthy control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnostic performance of the blood assay for differentiating benign and malignant breast disease using glycosylated extracellular vesicles analysis	The efficacy of the blood-based assay comparing with patholgic diagnosis, the gold standard, and imaging diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients≥18 years old；
Histologically confirmed breast cancer patients，Benign breast disease （ig. breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst）or No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)
Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments.
Subjects signed informed consent；

Exclusion Criteria:

A history of prior or concomitant malignancies;
advanced stage breast cancer (stage IV)；
Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
Pregnant or lactating women ；
Suspected or confirmed lesion was surgically removed；
Patients with incomplete clinical data；
Patients with poor compliance；
Patients with severe mental illness；
Patients had received blood transfusions during one month一；

Accepts Healthy Volunteers

Yes

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

Breat cancer, Benign breast disease and Healthy control

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhaoqing Fan, MD	Contact	+86-10-88197838		zhqfan@sina.com

Overall Officials

Name	Affiliation	Role
Zhaoqing Fan, MD	Breast center at Peking University Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Cancer Hospital	Recruiting	Beijing	Beijing Municipality	100142	China

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
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided