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A real world study of RecurIndex in predicting of the recurrence risk in Chinese patients with stage N0 luminal breast cancer

A real world study of RecurIndex in predicting of the recurrence risk in Chinese patients with stage N0 luminal breast cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047958
Enrollment
Unknown
Registered
2021-06-28
Start date
2020-06-10
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, female; 2. Histopathological examination after surgical resection was diagnosed as invasive breast cancer; hormone receptor ER and/or PR positive (IHC test, ER>=10%), HER2 negative (IHC/FISH test); 3. pT1-2N0 breast cancer patients; 4. The initial treatment is surgical treatment (breast-conserving surgery or total mastectomy); 5. Patients undergoing breast conserving surgery need to receive standard whole breast irradiation after surgery; 6. The minimum follow-up time is 5 years (sample time: 2013-2015); 7. All patients received endocrine therapy after surgery (premenopausal: tamoxifen or tamoxifen + OFS; aromatase inhibition + OFS; postmenopausal: tamoxifen or aromatase inhibition), and completed standard endocrine therapy ; 8. Patients receiving chemotherapy need to complete complete standard chemotherapy; 9. There are enough pathological sections for 28 gene detection (20 5um FFPE white films), and complete clinical information for formula analysis and calculation: the main contents are as follows: (1) Demographics: name, age; (2) Disease information: tumor size, lymph node status, date of diagnosis, hormone status, lymphatic or vascular invasion, pathological grade; (3) Treatment: date and treatment methods of surgery, radiotherapy, endocrine, chemotherapy, etc.; (4) Outcomes: date of last follow-up, recurrence (if any), date of death, cause of death.

Exclusion criteria

Exclusion criteria: 1. Received neoadjuvant therapy before surgery, including chemotherapy and other treatments; 2. Patients who have not completed complete treatment; 3. Receive radiation therapy for regional lymph nodes such as axillary lymph nodes; 4. History of other malignant tumors, except skin basal cell carcinoma; 5. Diagnosis of bilateral breast cancer.

Design outcomes

Primary

MeasureTime frame
distant metastasis-free survival;recurrence-free survival;

Secondary

MeasureTime frame
no locoregional recurrence rate;overall survival;

Countries

China

Contacts

Public ContactWang Haibo

The Affiliated Hospital of Qingdao University

hbwang66@126.com+86 18661805787

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026