Last updated: April 15, 2024
Sponsor: Singlera Genomics Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
NCT05858242
KYS-2022002
Ages 18-80 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
The first stage Inclusion Criteria: Women between the ages of 18 and 80 who are not pregnant or lactating; Meet any of thefollowing categories:
- Breast cancer Newly diagnosed breast cancer patients [according to breast cancer TNMstaging]; The patient was not accepted prior to blood collection Any breast cancerantitumor related treatment, including surgery, transplantation, radiation,chemotherapy, etc.
- precancerous lesions Dysplasia, carcinoma in situ, atypical hyperplasia, etc., noprevious history of malignant tumor.
- Benign lesions These include fibroadenoma of the breast, intraductal papilloma of thebreast, cystic hyperplasia of the breast, lobulated tumors of the breast, Plasma cellmastitis.
- Healthy people No abnormal breast, no history of malignancy within 5 years; Age 50years or above.
Exclusion
Exclusion Criteria:
- previous breast cancer;
- A history of other cancers;
- Patients who have received major surgical treatment such as blood transfusion ortransplantation 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 other diseases deemed unsuitable for inclusion by the researcher; The second stage Inclusion Criteria:
- Patients with definite pathological diagnosis of breast cancer who were to receiveradical 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, simpleexcision + sentinel lymph node biopsy and modified radical surgery, and on this basis,mastectomy plastic surgery, stage I reconstruction and other operations that have thesame radical treatment effect and do not affect the entire standardized treatment ofpatients
- Enrolled patients were newly treated breast cancer patients without prior malignanttumor history and treatment history Exclusion Criteria:
- 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 marrowtransplantation or received blood transfusion within the past month;
Study Design
Total Participants: 100
Study Start date:
March 07, 2023
Estimated Completion Date:
March 31, 2026
Study Description
Connect with a study center
Beijing Friendship Hospital Affiliated to Capital Medical University
Beijing, Beijing 100050
ChinaActive - Recruiting
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