Ovarian CancerNCT01258881
Retrospective Study of Ovarian Cancer Patients With Brain Metastasis
An observational study of Ovarian Cancer and Brain Metastases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are diagnosed at advanced stage which has the overall survival rates of only 19-30%. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer, Brain Metastases
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Dec 2011
- 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 25 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: ovarian cancer patients with brain metastasis
Who may be able to join
- Patients with ovarian cancer and brain metastasis
- Patients ovarian cancer from National Taiwan University Hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Wen-Fang Cheng, Professor, 886-2-23123456 ext. 71964, wenfangcheng@yahoo.com
About this study
Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are diagnosed at advanced stage which has the overall survival rates of only 19-30%. As the advance in the managements which prolonged the overall survival, metastatic lesion in rare location such as brain was noted in few patients of ovarian cancer in recent years. In the retrospective study, the investigators will review the medical records of the ovarian cancer patients with brain metastasis in the investigators hospital to investigate the incidence, clinical courses, optimal managements and possible prognostic factors in the rare condition.
Read the detailed description
The ovarian cancer patient treated at the Department of Obstetrics and Gynecology of the National Taiwan University Hospital were retrospectively collected. The cancer registration database was searched for the patients with ovarian carcinoma who brain metastases were also diagnosed. The medical records of these patients were reviewed with particular attention to the results of histo-pathological and radiologic reports. Patients with other synchronous primary brain tumor were excluded. The initial management of primary tumor, including the surgery and adjuvant chemotherapy, and the clinical courses and disease status, such as remission, recurrence and progression, were all carefully reviewed. The intra-cranial lesions were all diagnosed by imaging studies, including brain computed tomography (CT) and magnetic resonance imaging (MRI) scans. Therapeutic strategies for the metastatic lesions in the brain were also reviewed. All statistical analyses were performed using the SPSS 13.0 statistical software for Windows. P<0.05 was defined as statistical significance. Survival was measured from the time of initial diagnosis of brain metastasis until the date of death or last contact, and was presented by Kaplan-Meier curves.
- Conditions
- Ovarian Cancer, Brain Metastases
- Medical subject headings
- Ovarian Neoplasms, Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Fang Cheng, Professor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258881
- Sponsor's protocol ID
- 201004066R
- Status last verified
- Dec 2010
- First submitted
- 10 Dec 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Ovarian Cancer Patients With Brain Metastasis
- ClinicalTrials.gov ID
- NCT01258881
- Acronym / sponsor ID
- 201004066R
- Conditions
- Ovarian Cancer, Brain Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 13 Dec 2010 (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.
Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are diagnosed at advanced stage which has the overall survival rates of only 19-30%. As the advance in the managements which prolonged the overall survival, metastatic lesion in rare location such as brain was noted in few patients of ovarian cancer in recent years. In the retrospective study, the investigators will review the medical records of the ovarian cancer patients with brain metastasis in the investigators hospital to investigate the incidence, clinical courses, optimal managements and possible prognostic factors in the rare condition.
Detailed description
The ovarian cancer patient treated at the Department of Obstetrics and Gynecology of the National Taiwan University Hospital were retrospectively collected. The cancer registration database was searched for the patients with ovarian carcinoma who brain metastases were also diagnosed. The medical records of these patients were reviewed with particular attention to the results of histo-pathological and radiologic reports. Patients with other synchronous primary brain tumor were excluded. The initial management of primary tumor, including the surgery and adjuvant chemotherapy, and the clinical courses and disease status, such as remission, recurrence and progression, were all carefully reviewed. The intra-cranial lesions were all diagnosed by imaging studies, including brain computed tomography (CT) and magnetic resonance imaging (MRI) scans. Therapeutic strategies for the metastatic lesions in the brain were also reviewed. All statistical analyses were performed using the SPSS 13.0 statistical software for Windows. P<0.05 was defined as statistical significance. Survival was measured from the time of initial diagnosis of brain metastasis until the date of death or last contact, and was presented by Kaplan-Meier curves.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ovarian cancer patients with brain metastasis
Key inclusion criteria (2 listed)
- Patients with ovarian cancer and brain metastasis
- Patients ovarian cancer from National Taiwan University Hospital
Key exclusion criteria (1 listed)
- none
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2010.
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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.
Wen-Fang Cheng, Professor principal investigator
National Taiwan University Hospital
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 Ovarian Cancer and Brain Metastases, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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 13 Dec 2010. 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 Taiwan. 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 Wen-Fang Cheng, Professor (886-2-23123456 ext. 71964, wenfangcheng@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Dec 2010.