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Epithelial Ovarian Cancer | Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer

Epithelial Ovarian Cancer research study

What is the primary objective of this study?

To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian cancer and to validate this model.

Who is eligible to participate?

Inclusion Criteria: - Patients with FIGO stage I-IV epithelial ovarian cancer after staging or debulking surgery - Patients who is planned to receive (prospective cohort) ro who received (retrospective cohort) adjuvant chemotherapy with paclitaxel and carboplatin - Patients who have signed approved informed consent Exclusion Criteria: - Uncontrolled medical disease - Active infectious disease - Previous pelvic radiation therapy - Previous chemotherapy (prospective cohort) - Patients with disease which can cause neutropenia - Patients who will receive other targeted therapy or immunotherapy during adjuvant therapy (prospective cohort). - Pregnant or lactating woman

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Epithelial Ovarian Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Training cohortThis cohort is a prospective cohort to develop a risk prediction model. This cohort include patients who underwent staging operation or debulking operation for epithelial ovarian cancer and are planned to receive ajuvant chemotherapy with paclitaxel/carboplatin up to 6 cycles.

Validation cohortThis is a retrospective cohort for validation of a risk prediction model developed using training cohort. This is consisted with 600 patients with epithelial ovarian cancer who received adjuvant chemotherapy with paclitaxel/carboplatin after staging operation or debulking operation.

Study Status

Recruiting

Start Date: September 2012

Completed Date: May 2018

Phase: N/A

Type: Observational

Design:

Primary Outcome: Risk prediction model for grade 3-4 chemotherapy induced neutropenia

Secondary Outcome: The association between mannose-binding lectin 2 gene SNP and neutropenia

Study sponsors, principal investigator, and references

Principal Investigator: Jeong-Yeol Park, M.D., Ph.D.

Lead Sponsor: Asan Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01680575

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