Ovarian NeoplasmsNCT03291262
Survival Outcomes of Ovarian Malignancies in Chinese Population
An observational study of Ovarian Neoplasms and Survival, run by Lei Li at 1 site in China.
Trial summary
This study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in China and relevant risk factors in a prospective cohort study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasms, Survival
- What is being tested?
- Follow up for death and recurrence
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jan 2023
- How long will I take part?
- 10 Years
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with definite diagnosis of primary ovarian malignancies confirmed by pathologic examinations.
Who may be able to join
- Primary ovarian malignancies.
Who cannot join
- Metastatic malignancies to ovaries.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, China/Beiing, 100000
Lei L Li, MD, 13911988831 ext. +86, lileigh@163.com
About this study
This study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in China and relevant risk factors in a prospective cohort study.
- Conditions
- Ovarian Neoplasms, Survival
- Being tested
- Follow up for death and recurrence
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up for death and recurrenceOther
Patients are followed up to determine the specific date of diagnosis, recurrence and death.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Periods from diagnosis of ovarian cancer to death
Measured: 5 years
Progression-free survival
Periods from diagnosis of ovarian cancer or remission of disease to next recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291262
- Sponsor's protocol ID
- SOOM-1
- Status last verified
- Nov 2018
- First submitted
- 20 Sep 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun T, Li L. A cohort study of hypersensitivity reaction in patients with epithelial ovarian cancer treated with carboplatin. Int J Gynecol Cancer. 2019 Mar;29(3):566-571. doi: 10.1136/ijgc-2018-000072. Epub 2018 Dec 22.
PubMed 30833442
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcomes of Ovarian Malignancies in Chinese Population
- ClinicalTrials.gov ID
- NCT03291262
- Acronym / sponsor ID
- SOOM-1
- Conditions
- Ovarian Neoplasms, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 25 Sep 2017 (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.
This study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in China and relevant risk factors in a prospective cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with definite diagnosis of primary ovarian malignancies confirmed by pathologic examinations.
Key inclusion criteria (1 listed)
- Primary ovarian malignancies.
Key exclusion criteria (1 listed)
- Metastatic malignancies to ovaries.
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 |
|---|---|---|
| Follow up for death and recurrencePatients are followed up to determine the specific date of diagnosis, recurrence and death. | Other | – |
Primary outcome
Overall survival
Time frame: 5 years
Periods from diagnosis of ovarian cancer to death
Progression-free survival
Time frame: 5 years
Periods from diagnosis of ovarian cancer or remission of disease to next recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 30833442Sun T, Li L. A cohort study of hypersensitivity reaction in patients with epithelial ovarian cancer treated with carboplatin. Int J Gynecol Cancer. 2019 Mar;29(3):566-571. doi: 10.1136/ijgc-2018-000072. Epub 2018 Dec 22.
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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.
Lei Li, MD principal investigator
Peking Union Medical College 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 Neoplasms and Survival, run by Lei Li at 1 site in China.
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 14 Nov 2018. 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 China. 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 Lei Li, MD (13911988831 ext. +86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291262, which also lists 1 linked publication.
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 14 Nov 2018.