Clinical trial · Observational
Whole Genome Sequencing in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention needed | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- prospective study
- description
- The prospective study group includes patients aged 19 years or older who have provided written consent for participation, have the capability to consent voluntarily, are eligible for tissue examination and surgical removal for sample collection, and have confirmed or suspected breast cancer for pathological confirmation.
- interventionNames
- Other: no intervention needed
- label
- Retrospective study
- description
- The retrospective study group includes patients who have been histologically confirmed with breast cancer and whose breast cancer tissues collected between 2012 and 2023 are stored in the Samsung Seoul Hospital Human Biobank and available for distribution.
- interventionNames
- Other: no intervention needed
Primary outcomes (1)
- measure
- Establishing individual genetic characteristics of breast cancer patients through WGS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
\[Prospective study\] 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.
References
Publications (0)
Data not yet available