Whole Genome Sequencing in Breast Cancer
Recruiting · NCT06334471 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to conduct whole genome sequencing in breast cancer patients to elucidate individual genetic characteristics and their correlation with breast cancer subtypes. The primary objective is to establish new treatment guidelines aligned with the paradigm shift in precision medicine. The study will include both prospective and retrospective cohorts totaling 1200 participants. Prospective participants must provide consent and be eligible for tissue collection, while retrospective participants must have histologically confirmed breast cancer and available tissue samples from Samsung Medical Center Biobank. The study period spans 3 years for subject enrollment and 5 years for follow-up observations, with an expected completion date of December 31, 2030.
Who can take part
Inclusion criteria
- Patients who have consented to both the patient consent form and the consent for the use of human-derived materials.
- Patients who are aged 19 years or older at the time of signing the consent form.
- Patients capable of providing written consent to participate voluntarily in the study.
- Patients eligible for tissue examination and surgical removal to facilitate sample collection.
- Patients histologically confirmed with breast cancer or undergoing tissue examination for pathological confirmation due to imaging findings suggestive of breast cancer.
Exclusion criteria
- Patients who do not understand or refuse to consent in writing.
- Patients for whom obtaining sufficient samples is challenging.
- Patients who refuse genetic testing.
- \[Retrospective study\]
- Inclusion Criteria:
- Patients histologically confirmed with breast cancer.
- Patients for whom breast cancer tissues collected between 2012 and 2023 are stored in the Samsung Seoul Hospital Biobank and available for distribution.
- Exclusion Criteria:
- \- Patients for whom sufficient tissue for analysis is not adequately stored.
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, South Korea