Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genomic Profiling of the Residual Disease of Advanced-stage Ovarian Cancer After Neoadjuvant Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491033
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Advanced-stage Ovarian Cancer Drug: chemotherapy

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genomic Profiling of the Residual Disease of Advanced-stage Ovarian Cancer After Neoadjuvant Chemotherapy
Actual Study Start Date : August 28, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
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.
Drug: chemotherapy
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.




Primary Outcome Measures :
  1. genomic profiling [ Time Frame: 3 months ]
    demonstrates the spectrum of genomic alterations/ profiling present in residual disease after neoadjuvant chemotherapy.


Secondary Outcome Measures :
  1. immunohistochemistry [ Time Frame: 3 months ]
    To evaluate the prognostic significance of BRCA-1 IHC in residual disease after neoadjuvant chemotherapy in ovarian cancer


Biospecimen Retention:   Samples With DNA
Formalin-fixed paraffin embedded


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tirtiary medical center
Criteria

Inclusion Criteria:

  • patients with pathologically confirmed epithelial ovarian cancer who received at least 1 cycle of neoadjuvant chemotherapy
  • The patient inclusion criteria included 1) high grade serous carcinoma 2) stage III/IV disease 3) availability of clinical data and tumor tissue 4) viable residual tumors after neoadjuvant chemotherapy.

Exclusion Criteria:

  • patients with complete pathologic response (CRS 3) as IHC staining was insufficient or unavailable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491033


Locations
Layout table for location information
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03491033    
Other Study ID Numbers: 4-2017-0632
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
advanced-stage ovarian cancer
neoadjuvant chemotherapy
residual disease
genomic profiling
immunohistochemistry
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type