Genomic Profiling of the Residual Disease of Advanced-stage Ovarian Cancer After Neoadjuvant Chemotherapy
1 other identifier
observational
250
1 country
1
Brief Summary
Tumor response to NAC predicts survival and can be considered a surrogate prognostic marker. Three tiered chemotherapy response score (CRS) of omental tissue sections showed a significant association with survival. In patients with CRS 1 or 2, NAC selects a subpopulation of chemotherapy resistant tumor cells. This study will examine comprehensive molecular analyses on the residual disease of 104 clinically defined high-grade serous carcinoma after NAC, including next-generation sequencing on 14 matched pretreatment biopsies. This information together with immune marker expression and BRCA expression, will provide a unique opportunity to guide biomarker-driven adjuvant studies targeting these chemotherapy-resistant tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedFirst Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 6, 2018
CompletedApril 10, 2018
March 1, 2018
2 months
March 30, 2018
April 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
genomic profiling
demonstrates the spectrum of genomic alterations/ profiling present in residual disease after neoadjuvant chemotherapy.
3 months
Secondary Outcomes (1)
immunohistochemistry
3 months
Study Arms (1)
advanced-stage ovarian cancer group
250 patients with pathologically confirmed epithelial ovarian cancer who received at least 1 cycle of NAC at Yonsei Cancer Hospital from 2006 to 2017.
Interventions
All of the patients in this study underwent NAC regimens consisting of taxane and platinum combination chemotherapy. After NAC, all of the patients underwent interval debulking surgery. Subsequently, additional cycles of chemotherapy were administered after IDS to complete a total of 6 cycles at the discretion of the treating physician.
Eligibility Criteria
tirtiary medical center
You may qualify if:
- patients with pathologically confirmed epithelial ovarian cancer who received at least 1 cycle of neoadjuvant chemotherapy
You may not qualify if:
- patients with complete pathologic response (CRS 3) as IHC staining was insufficient or unavailable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance hospital
Seoul, 03722, South Korea
Biospecimen
Formalin-fixed paraffin embedded
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 6, 2018
Study Start
August 28, 2017
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
April 10, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share