Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Asan Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Jeong-Yeol Park, Asan Medical Center Identifier:
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

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 ]

Secondary Outcome Measures:
  • The association between mannose-binding lectin 2 gene SNP and neutropenia [ Time Frame: 1 year ]

Estimated Enrollment: 750
Study Start Date: September 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.
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.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes 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.


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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01680575

Contact: Jeong-Yeol Park, M.D., Ph.D. 82-2-3010-3646

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
Principal Investigator: Jeong-Yeol Park, M.D., Ph.D. Asan Medical Center
  More Information

Responsible Party: Jeong-Yeol Park, Clinical Assistant Professor, Asan Medical Center Identifier: NCT01680575     History of Changes
Other Study ID Numbers: NEPACA-OVCA
Study First Received: September 4, 2012
Last Updated: September 8, 2012

Keywords provided by Asan Medical Center:
Epithelial ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Leukocyte Disorders
Hematologic Diseases
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017