Whole genome sequencing for breast cancer patients
Whole Genome Sequencing in Breast Cancer
This study is testing how whole genome sequencing can help understand the different types of breast cancer by looking at the genetic makeup of 1,200 breast cancer patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Inocras Korea Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06334471 on ClinicalTrials.gov |
What this trial studies
This observational study aims to conduct whole genome sequencing (WGS) in breast cancer patients to analyze their individual genetic characteristics and correlate these with different breast cancer subtypes. It will include both prospective participants, who must consent and be eligible for tissue collection, and retrospective participants with existing tissue samples from the Samsung Medical Center Biobank. The study will enroll a total of 1200 participants over a period of three years, followed by five years of follow-up observations, with the goal of refining treatment guidelines based on precision medicine. The comprehensive data collected will include clinical, pathological, and genomic information to identify potential prognostic factors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 years or older with histologically confirmed breast cancer who can provide consent for tissue collection.
Not a fit: Patients who refuse genetic testing or cannot provide sufficient tissue samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for breast cancer patients.
How similar studies have performed: Other studies utilizing whole genome sequencing in cancer have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
\[Prospective study\] 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.
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: JeongSeok Lee, MD
- Email: jslee@inocras.com
- Phone: 82-2-587-0109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.