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NCT01680575 Clinical Trial

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

Epithelial Ovarian Cancer Clinical Trial

Official title:
Development of a Risk Model Predicting Chemotherapy-induced Grade 3-4 Neutropenia by Paclitaxel/Carboplatin in Epithelial Ovarian Cancer: Prospective Observational Study for Model Development and Retrospective Study for Validation of Developed Model

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01680575
Other study ID # NEPACA-OVCA
Secondary ID
Status Recruiting
Phase N/A
First received September 4, 2012
Last updated May 27, 2017
Start date September 2012
Est. completion date May 2018

Study information
Verified date May 2017
Source Asan Medical Center
Contact Jeong-Yeol Park, M.D., Ph.D.
Phone 82-2-3010-3646
Email catgut1-0@hanmail.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 750
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Risk prediction model for grade 3-4 chemotherapy induced neutropenia 1 year
Secondary The association between mannose-binding lectin 2 gene SNP and neutropenia 1 year
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