Whole Genome Sequencing in Breast Cancer

NCT06334471 | Recruiting

• 1 other identifier: INCS_WGS_B-001
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Breast Cancer; whole genome sequencing

Outcome Measures

Primary Outcomes (1)

• Establishing individual genetic characteristics of breast cancer patients through WGS

  The primary goal of this study is to elucidate the individual genetic traits of breast cancer patients through comprehensive analysis of their whole genome and observational factors.

  December.31.2030

Secondary Outcomes (1)

• Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer

  December.31.2030

Study Arms (2)

prospective study

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.

Other: no intervention needed

Retrospective study

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.

Other: no intervention needed

Interventions

no intervention needed OTHER

no intervention needed

Retrospective study; prospective study

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective study : 500 Retrospective study : 700

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not understand or refuse to consent in writing.
• Patients for whom obtaining sufficient samples is challenging.
• Patients who refuse genetic testing.
• \[Retrospective study\]
• 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.
• \- Patients for whom sufficient tissue for analysis is not adequately stored.

Sponsors & Collaborators

• Inocras Korea Inc.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In both prospective and retrospective studies, individual identifiers for each research subject and specimen are anonymized, and research subject numbers are assigned to manage the specimens. Specimens collected in the prospective study of this research will be identified by coded numbers, and their retention and disposal will be determined based on the specified retention period in the informed consent form, provision availability for other research purposes, and procedures for handling personal information upon provision.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• JeongSeok Lee

  Inocras Korea Inc.

  STUDY CHAIR

Central Study Contacts

JeongSeok Lee, MD

CONTACT

82-2-587-0109; jslee@inocras.com

HyunJung Lee

CONTACT

82-2-587-0109; hjlee@inocras.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 28, 2024
• Study Start: August 2, 2022
• Primary Completion: August 2, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)