NCT01680575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

5.7 years

First QC Date

September 4, 2012

Last Update Submit

May 27, 2017

Conditions

Epithelial Ovarian Cancer

Keywords

NeutropeniaPaclitaxelCarboplatinEpithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • Risk prediction model for grade 3-4 chemotherapy induced neutropenia

    1 year

Secondary Outcomes (1)

  • The association between mannose-binding lectin 2 gene SNP and neutropenia

    1 year

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialNeutropenia

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Jeong-Yeol Park, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Yeol Park, M.D., Ph.D.

CONTACT

82-2-3010-3646catgut1-0@hanmail.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

KR(1)