Serous Ovarian CarcinomaLOGYSTNCT05741554
Low Grade Serous Ovarian Carcinoma and Uterine Involvement : Should Hysterectomy be the Rule
An observational study of Serous Ovarian Carcinoma and Low Grade Serous Ovarian Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Investigators studied a population of 28 low grade serous ovarian carcinoma treated in Hospices civils de Lyon between 2000 and 2022. The primary objective is to determinate the rate of myometrial involvement by the cancer at pathology examination. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Serous Ovarian Carcinoma, Low Grade Serous Ovarian Carcinoma
- What is being tested?
- Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 10 Oct 2022
- 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
- Child, Adult, Older adult
Study population: All patients treated in hospices Civils de Lyon for a Low grade serous ovarian cancer between January 2000 and May 2022
Who may be able to join
- 18 years old or more
- low grade serous ovarian cancer (MDACC classification)
- Grade 1 serous ovarian carcinoma (Silverberg classification)
Who cannot join
- no sufficient data available
- grade 2 and 3 serous ovarian carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LOw Grade Serous Ovarian Carcinoma and Uterine Involvement : Should hYSTerectomy be the Rule
Investigators studied a population of 28 low grade serous ovarian carcinoma treated in Hospices civils de Lyon between 2000 and 2022. The primary objective is to determinate the rate of myometrial involvement by the cancer at pathology examination. Then, investigators compared patients with or without myometrial involvement : survival parameters, predictive factors of myometrial involvement (age, CA 125 level, surgery characteristics, pathology characteristics).
- Being tested
- Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.
- Keywords
- Serous ovarian carcinoma, Low grade serous ovarian carcinoma, Fertility sparring surgery, Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.Other
Presence of uterine myometrial metastasis at pathology examination after cytoreductive surgery
| Study group | Role | What they receive |
|---|---|---|
| Myometrial involvement | Myometrial involvement by cancer metastasis after pathology examination Receives: Other: Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma. | |
| No myometrial involvement | Absence of myometrial involvement by cancer metastasis after pathology examination Receives: Other: Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of myometrial involvement
Myometrial involvement after pathology examination
Measured: After pathology examination, average 2 to 3 weeks after cytoreductive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Sep 2021
- Primary completion1 Jun 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serous Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741554
- Sponsor's protocol ID
- 22-5035
- Other IDs
- 69HCL23_0175
- Acronym
- LOGYST
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOw Grade Serous Ovarian Carcinoma and Uterine Involvement : Should hYSTerectomy be the Rule
- ClinicalTrials.gov ID
- NCT05741554
- Acronym / sponsor ID
- LOGYST / 22-5035
- Keywords
- Serous ovarian carcinoma, Low grade serous ovarian carcinoma, Fertility sparring surgery, Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 23 Feb 2023 (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.
Investigators studied a population of 28 low grade serous ovarian carcinoma treated in Hospices civils de Lyon between 2000 and 2022. The primary objective is to determinate the rate of myometrial involvement by the cancer at pathology examination. Then, investigators compared patients with or without myometrial involvement : survival parameters, predictive factors of myometrial involvement (age, CA 125 level, surgery characteristics, pathology characteristics).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myometrial involvement | – | Other: Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.Myometrial involvement by cancer metastasis after pathology examination |
| No myometrial involvement | – | Other: Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.Absence of myometrial involvement by cancer metastasis after pathology examination |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated in hospices Civils de Lyon for a Low grade serous ovarian cancer between January 2000 and May 2022
Key inclusion criteria (3 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.Presence of uterine myometrial metastasis at pathology examination after cytoreductive surgery | Other | Myometrial involvement, No myometrial involvement |
Primary outcome
Percentage of myometrial involvement
Time frame: After pathology examination, average 2 to 3 weeks after cytoreductive surgery
Myometrial involvement after pathology examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Serous Ovarian Carcinoma and Low Grade Serous Ovarian Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 23 Feb 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of myometrial involvement (time frame: After pathology examination, average 2 to 3 weeks after cytoreductive surgery). 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 23 Feb 2023.