Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT07052734
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed age: 18-75 years.
2. Early-stage invasive breast cancer, pN0-1.
3. Molecular subtype: HR-positive (ER and/or PR positive), HER2-negative.
4. At least five years of follow-up records (including cases with disease progression within five years and documented records).
5. Sufficient FFPE samples for sectioning or frozen samples for RNA extraction and subsequent testing.
Exclusion Criteria:
1. FFPE samples with tumor content \<20%, and inability to enrich tumor regions through cutting.
2. Insufficient extracted nucleic acid quantity or severe degradation preventing further experiments.
3. Failure in RT-PCR amplification of housekeeping genes.
4. Multiple primary breast cancers or a history of ipsilateral or contralateral breast cancer.
5. Disease progression unrelated to breast cancer.
6. Lack of prior signed consent for retrospective scientific research or exemption from informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07052734
Study Brief:
Protocol Section:
NCT07052734