Epithelial Ovarian CancerNCT01680575
Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer
An observational study of Epithelial Ovarian Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- How many people
- 750 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
Jeong-Yeol Park, M.D., Ph.D.
About this study
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
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.
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Neutropenia, Paclitaxel, Carboplatin, Epithelial ovarian cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk prediction model for grade 3-4 chemotherapy induced neutropenia
Measured: 1 year
Secondary outcomes (1)
The association between mannose-binding lectin 2 gene SNP and neutropenia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Yeol Park, Asan Medical Center
- Investigators
- Jeong-Yeol Park, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680575
- Sponsor's protocol ID
- NEPACA-OVCA
- Status last verified
- May 2017
- First submitted
- 4 Sep 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01680575
- Acronym / sponsor ID
- NEPACA-OVCA
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Neutropenia, Paclitaxel, Carboplatin, Epithelial ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Uncontrolled medical disease
- Active infectious disease
- Previous pelvic radiation therapy
- Previous chemotherapy (prospective cohort)
- Patients with disease which can cause neutropenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk prediction model for grade 3-4 chemotherapy induced neutropenia
Time frame: 1 year
1 secondary outcome
The association between mannose-binding lectin 2 gene SNP and neutropenia
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Yeol Park, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Yeol Park, M.D., Ph.D. (82-2-3010-3646, catgut1-0@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk prediction model for grade 3-4 chemotherapy induced neutropenia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.