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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01680575

Enrollment

750

Registered

2012-09-07

Start date

2012-09-30

Completion date

2018-05-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer

Keywords

Neutropenia, Paclitaxel, Carboplatin, Epithelial ovarian cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Risk prediction model for grade 3-4 chemotherapy induced neutropenia	1 year

Secondary

Measure	Time frame
The association between mannose-binding lectin 2 gene SNP and neutropenia	1 year

Countries

South Korea

Contacts

Primary ContactJeong-Yeol Park, M.D., Ph.D.

catgut1-0@hanmail.net82-2-3010-3646

Outcome results