Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

NCT ID: NCT05649475

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-31

Study Completion Date

2025-07-31

Brief Summary

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In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.

Detailed Description

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Conditions

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Stage I-III Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving neoadjuvant therapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient is ≥ 18 years-old at the time of consent to participate this trial
* Patients with stage I-III invasive breast cancer
* No prior anti-cancer treatment
* Felt to be a possible candidate for neoadjuvant therapy by their physician

Exclusion Criteria

* Known to have other aggressive malignant tumor in the past 5 years.
* Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.
* There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
* The investigator determines that subjects are not appropriate to participate in the study due to other factors.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GeneCast Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunxiang Zhou

Role: CONTACT

+8615868131018

Facility Contacts

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Yiding Chen

Role: primary

Other Identifiers

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2021-0532

Identifier Type: -

Identifier Source: org_study_id

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