Whole Genome Sequencing in Breast Cancer (WGS SIT)

April 2, 2024 updated by: Inocras Korea Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer is a complex disease with diverse genetic characteristics, necessitating personalized treatment approaches. This study proposes to conduct whole genome sequencing (WGS) to comprehensively analyze the genetic landscape of breast cancer patients, aiming to identify novel genetic alterations and their implications for disease classification and treatment response.

The primary objective of this research is to elucidate the individual genetic profiles of breast cancer patients through WGS and subsequent analysis. By characterizing the genomic alterations unique to each patient, this study seeks to refine breast cancer subtyping, facilitate the discovery of innovative treatment strategies, and optimize therapeutic decision-making.

This multicenter study will enroll a total of 1200 participants, comprising both prospective and retrospective cohorts. Prospective participants will be recruited based on specific inclusion criteria, including age, consent for tissue collection, and histologically confirmed breast cancer diagnosis. Retrospective participants will be identified from existing breast cancer tissue samples collected between 2012 and 2023 and stored in the Samsung Medical Center Biobank.

The study will involve comprehensive data collection, including clinical, pathological, and genomic information. Participants will undergo WGS analysis of tumor samples, and the resulting genomic data will be correlated with clinical outcomes to identify potential prognostic markers and therapeutic targets.

The research will be conducted under the supervision of Professor Yeonhee Park, an expert in hematology-oncology at Samsung Medical Center, in collaboration with Inocras Inc, the study sponsor. The study period will span three years for subject enrollment, followed by a five-year follow-up observation period. The expected completion date for the study is December 31, 2030.

This study holds the potential to significantly advance our understanding of the molecular basis of breast cancer and pave the way for the development of personalized treatment approaches tailored to individual patients' genetic profiles.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Yeon Hee Park, MD
        • Principal Investigator:
          • Yeon Hee Park, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Prospective study : 500 Retrospective study : 700

Description

[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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
no intervention needed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Establishing individual genetic characteristics of breast cancer patients through WGS
Time Frame: December.31.2030
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer
Time Frame: December.31.2030
Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer
December.31.2030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inocras Korea Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: JeongSeok Lee, Inocras Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCS_WGS_B-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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