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

NCT05858242 | Recruiting

• 1 other identifier: KYS-2022002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

ctDNA methylation; Relapse monitoring

Outcome Measures

Primary Outcomes (2)

• Finding the characteristic ctDNA methylation targets of breast cancer

  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

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Women between the ages of 18 and 80 who are not pregnant or lactating; Meet any of the following categories:
• 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.
• precancerous lesions Dysplasia, carcinoma in situ, atypical hyperplasia, etc., no previous history of malignant tumor.
• 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.
• Healthy people No abnormal breast, no history of malignancy within 5 years; Age 50 years or above.

You may not qualify if:

• previous breast cancer;
• A history of other cancers;
• Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months
• Participate in other interventional clinical researchers, pregnant or lactating women, or patients suffering from autoimmune diseases, genetic diseases, mental disorders, etc., within 3 months.
• Patients with definite pathological diagnosis of breast cancer who were to receive radical surgery after preoperative evaluation for initial treatment
• Women aged between 18 and 80 who are not pregnant or lactating;
• 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
• Enrolled patients were newly treated breast cancer patients without prior malignant tumor history and treatment history
• Stage IV breast cancer patients, or ECOG score \> 2.
• A history of malignant tumor or other hereditary diseases;
• Have received organ transplantation, stem cell transplantation, bone marrow transplantation or received blood transfusion within the past month;

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Beijing Friendship Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (2)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Oeffinger KC, Fontham ET, Etzioni R, Herzig A, Michaelson JS, Shih YC, Walter LC, Church TR, Flowers CR, LaMonte SJ, Wolf AM, DeSantis C, Lortet-Tieulent J, Andrews K, Manassaram-Baptiste D, Saslow D, Smith RA, Brawley OW, Wender R; American Cancer Society. Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA. 2015 Oct 20;314(15):1599-614. doi: 10.1001/jama.2015.12783.

  PMID: 26501536 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Liu Rui, Doctor

  Singlera Genomics Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Huiming, Doctor

CONTACT

13699115560; zhanghm1977@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 15, 2023
• Study Start: March 7, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)