ctDNA Monitoring in Early Breast Cancer | NCT04353557

Studies
ctDNA Monitoring in Early Breast Cancer

NCT04353557

Sponsor

Geneplus-Beijing Co. Ltd.

Status

Recruiting

Last Update Posted

Jul 18, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

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

Jul 2024

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

Nov 29, 2019Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Apr 16, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 20, 2020Actual

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

Jul 16, 2024

Last Update Posted Date

Jul 18, 2024Actual

Name	Class
Army Medical University, China	OTHER

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 observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.

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

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive ctDNA detection at first post-operative timepoint	The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint	1 month post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Positive ctDNA detection at post-operative timepoints	The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints	6/12/18/24/30 months
Association between ctDNA detection and time to recurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 to 80 years old
Histologically proven primary breast cancer with clinical stage I-III
Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
Expected to achieve R0 resection.
Estimated lifetime is more than 3 months.
Signed Informed Consent Form
Consent to provide research blood samples.

Exclusion Criteria:

Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.
Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.
Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with stage I-III breast cancer who planed to receive curative-intent treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan Xu, M.D.	Contact	(+86)159 2310 0038		xy931@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Army Medical Center of PLA, China	Recruiting	Chongqing	Chongqing Municipality	400042	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