ctDNA Monitoring in Early Breast Cancer

February 21, 2024 updated by: Geneplus-Beijing Co. Ltd.

Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yan Xu, M.D.
  • Phone Number: (+86)159 2310 0038
  • Email: xy931@163.com

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Army Medical Center of PLA, China
        • Contact:
          • Yan Xu, M.D.
          • Phone Number: (+86)159 2310 0038
          • Email: xy931@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive ctDNA detection at post-operative timepoints
Time Frame: 6/12/18/24/30 months
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
Time Frame: 1 month post-surgery
Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison.
1 month post-surgery
Association between ctDNA detection and time to recurrence
Time Frame: 6/12/18/24/30 months
Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA
6/12/18/24/30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geneplus-Beijing Co. Ltd.

Collaborators

Army Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Geneplus2020BC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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