Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334471
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-20
Brief Title:
Whole Genome Sequencing in Breast Cancer
Sponsor:
Inocras Korea Inc
Organization:
Inocras Korea Inc
Study Overview
Official Title:
Whole Genome Sequencing in Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WGS SIT
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None