Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer
Verified September 2012 by Asan Medical Center
Information provided by (Responsible Party):
Jeong-Yeol Park, Asan Medical Center
First received: September 4, 2012
Last updated: September 8, 2012
Last verified: September 2012
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.
Epithelial Ovarian Cancer
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- Risk prediction model for grade 3-4 chemotherapy induced neutropenia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The association between mannose-binding lectin 2 gene SNP and neutropenia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
This 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.
This 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.
|Ages Eligible for Study:
||20 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Training cohort (prospective cohort): Patients with epithelial ovarian cancer who underwent staging operation or debulking surgery at university hospital and who are planned to receive adjuvant chemotherapy with paclitaxel and carboplatin.
Validation cohort (retrospective cohort): Patients with epithelial ovarian cancer who received adjuvant chemotherapy with paclitaxel and carboplatin after staging operation or debulking operation.
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01680575
|Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
|Seoul, Korea, Republic of, 138-736 |
|Contact: Jeong-Yeol Park, M.D., Ph.D. |
Asan Medical Center
||Jeong-Yeol Park, M.D., Ph.D.
||Asan Medical Center
No publications provided
||Jeong-Yeol Park, Clinical Assistant Professor, Asan Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 4, 2012
||September 8, 2012
||Korea: Asan Medical Center Institutional Review Board
Keywords provided by Asan Medical Center:
Epithelial ovarian cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic