Ovarian CancerNCT04414683
Factors Affecting the Prognosis of Early Ovarian Cancer
An observational study of Ovarian Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To elucidate factors affecting survival of early stage ovarian cancer Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- staging surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Apr 2020to 31 Dec 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with early stage ovarian cancer
Who may be able to join
- early stage ovarian cancer
Who cannot join
- Nil.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
To elucidate factors affecting survival of early stage ovarian cancer
Read the detailed description
To analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade, intraoperative rupture, and laparoscopy vs. laparotomy, etc.
- Conditions
- Ovarian Cancer
- Being tested
- staging surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
staging surgeryProcedure or surgery
laparoscopic or laparotomic staging surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors affecting overall survival of early ovarian cancer
Measured: 10 years
Secondary outcomes (1)
Factors affecting progression-free survival of early ovarian cancer
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start13 Apr 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414683
- Sponsor's protocol ID
- 109058-E
- Status last verified
- Sep 2023
- First submitted
- 31 May 2020
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Prognosis of Early Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04414683
- Acronym / sponsor ID
- 109058-E
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Jun 2020 (actual)
- 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 elucidate factors affecting survival of early stage ovarian cancer
Detailed description
To analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade, intraoperative rupture, and laparoscopy vs. laparotomy, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with early stage ovarian cancer
Key inclusion criteria (1 listed)
- early stage ovarian cancer
Key exclusion criteria (1 listed)
- Nil.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| staging surgerylaparoscopic or laparotomic staging surgery | Procedure or surgery | – |
Primary outcome
Factors affecting overall survival of early ovarian cancer
Time frame: 10 years
1 secondary outcome
Factors affecting progression-free survival of early ovarian cancer
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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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.
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, run by Far Eastern Memorial 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 1 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 15 Sep 2023. 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 Sheng-Mou Hsiao, MD (+886919302632, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors affecting overall survival of early ovarian cancer (time frame: 10 years). 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 15 Sep 2023.