Study on Early Auxiliary Diagnosis and Postoperative Recurrence Monitoring of Breast Cancer

April 15, 2024 updated by: Singlera Genomics Inc.

Early Auxiliary Diagnosis and Postoperative Recurrence Monitoring of Breast Cancer Based on Plasma ctDNA Methylation Markers

This study screened and identified effective methylation markers in breast cancer, established a detection system for early screening and early diagnosis, and provided a research basis for the embryonic form of non-invasive breast cancer early screening products in later incubation. Then, the plasma ctDNA polygene methylation test was performed for early and middle stage breast cancer patients who were to receive radical surgery for initial treatment, and the predictive effect of postoperative plasma ctDNA methylation status on postoperative prognosis of breast cancer was discussed. In addition, the application value of dynamic monitoring of ctDNA methylation in plasma for postoperative recurrence risk monitoring was explored through regular postoperative follow-up of stage I-III breast cancer patients undergoing radical surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. This study will be divided into two stages. The first stage will complete the screening, identification, model construction and target verification of polygene methylation markers in the blood of breast cancer patients. The second stage will explore its application in monitoring prognosis and recurrence after radical mastectomy.
  2. The first stage (inclusion detection period) : By detecting the DNA methylation characteristics of breast cancer (including tissue and plasma) and non-breast cancer samples (breast tissue/plasma of healthy people, and plasma samples of patients with benign breast lesions), screening, identification and verification of plasma ctDNA polygene methylation markers that can distinguish the differences between breast cancer and non-breast cancer samples are carried out.
  3. The second stage (postoperative monitoring and evaluation) : The enrolled group was the initially treated patients who planned to undergo radical mastectomy. Plasma methylation markers were detected before surgery at baseline, and dynamic monitoring of plasma ctDNA polygene methylation detection, related tumor markers and imaging examinations were performed 3 weeks after surgery (or before the start of chemotherapy) and regular follow-up review (once every 3 months for 2 years). To explore the clinical application value of ctDNA methylation status in postoperative breast cancer surgery and follow-up monitoring.

Study Type

Observational

Enrollment (Estimated)

100

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital Affiliated to Capital Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

1000-1050 samples were used for molecular screening model construction and 100 breast cancer patients awaiting radical surgery were used for 2-year follow-up after treatment

Description

The first stage Inclusion Criteria：

Women between the ages of 18 and 80 who are not pregnant or lactating; Meet any of the following categories:

  1. Breast cancer Newly diagnosed breast cancer patients [according to breast cancer TNM staging]; The patient was not accepted prior to blood collection Any breast cancer antitumor related treatment, including surgery, transplantation, radiation, chemotherapy, etc.
  2. precancerous lesions Dysplasia, carcinoma in situ, atypical hyperplasia, etc., no previous history of malignant tumor.
  3. Benign lesions These include fibroadenoma of the breast, intraductal papilloma of the breast, cystic hyperplasia of the breast, lobulated tumors of the breast, Plasma cell mastitis.
  4. Healthy people No abnormal breast, no history of malignancy within 5 years; Age 50 years or above.

Exclusion Criteria:

  1. previous breast cancer;
  2. A history of other cancers;
  3. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months
  4. Participate in other interventional clinical researchers, pregnant or lactating women, or patients suffering from autoimmune diseases, genetic diseases, mental disorders, etc., within 3 months.
  5. Patients with other diseases deemed unsuitable for inclusion by the researcher;

The second stage Inclusion Criteria：

  1. Patients with definite pathological diagnosis of breast cancer who were to receive radical surgery after preoperative evaluation for initial treatment
  2. Women aged between 18 and 80 who are not pregnant or lactating;
  3. The radical surgery to be received includes mastectomy radical surgery, simple excision + sentinel lymph node biopsy and modified radical surgery, and on this basis, mastectomy plastic surgery, stage I reconstruction and other operations that have the same radical treatment effect and do not affect the entire standardized treatment of patients
  4. Enrolled patients were newly treated breast cancer patients without prior malignant tumor history and treatment history

Exclusion Criteria:

  1. Stage IV breast cancer patients, or ECOG score > 2.
  2. A history of malignant tumor or other hereditary diseases;
  3. Have received organ transplantation, stem cell transplantation, bone marrow transplantation or received blood transfusion within the past month;

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

Cohorts and Interventions

Group / Cohort
Early and mid-stage breast cancer patients awaiting radical surgery
To explore the predictive effect of plasma ctDNA methylation on postoperative prognosis of breast cancer and the application value of monitoring postoperative recurrence risk through regular postoperative follow-up of stage I-III breast cancer patients undergoing radical surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finding the characteristic ctDNA methylation targets of breast cancer
Time Frame: assessed up to 36 months
Establish and verify the early screening model of breast cancer, evaluate the specificity and sensitivity of the model.
assessed up to 36 months
To explore the application of postoperative ctDNA methylation in the evaluation of the curative effect of breast cancer surgery and follow-up monitoring
Time Frame: assessed up to 36 months
The positive and negative prediction rates of ctDNA methylation markers in plasma were analyzed for the recurrence rate 2 years after radical mastectomy for stage I-III breast cancer.
assessed up to 36 months

Collaborators and Investigators

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

Sponsor

Singlera Genomics Inc.

Collaborators

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Liu Rui, Doctor, Singlera Genomics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 7, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYS-2022002

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.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe