Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer
This study is currently recruiting participants.
Verified September 2012 by Asan Medical Center
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Jeong-Yeol Park, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01680575
First received: September 4, 2012
Last updated: September 8, 2012
Last verified: September 2012
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Purpose
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.
| Condition |
|---|
|
Epithelial Ovarian Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
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: | 750 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Training cohort
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.
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Validation cohort
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. |
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680575
Contacts
| Contact: Jeong-Yeol Park, M.D., Ph.D. | 82-2-3010-3646 | catgut1-0@hanmail.net |
Locations
| Korea, Republic of | |
| Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Jeong-Yeol Park, M.D., Ph.D. | |
Sponsors and Collaborators
Asan Medical Center
Investigators
| Principal Investigator: | Jeong-Yeol Park, M.D., Ph.D. | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Jeong-Yeol Park, Clinical Assistant Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT01680575 History of Changes |
| Other Study ID Numbers: | NEPACA-OVCA |
| Study First Received: | September 4, 2012 |
| Last Updated: | September 8, 2012 |
| Health Authority: | Korea: Asan Medical Center Institutional Review Board |
Keywords provided by Asan Medical Center:
|
Neutropenia Paclitaxel Carboplatin Epithelial ovarian cancer |
Additional relevant MeSH terms:
|
Neutropenia Ovarian Neoplasms Neoplasms, Glandular and Epithelial Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013