Epithelial Ovarian CancerNCT06483399
Research on Nutritional Risk Indexes and Inflammatory Indicators in Postoperative Complications and Prognosis of Epithelial Ovarian Cancer Patients
An observational study of Epithelial Ovarian Cancer, run by Qinglei Gao.
Trial summary
The goal of this observational study is to explore the influence and predictive significance of nutritional risk indicators and inflammatory indicators on postoperative complications and prognosis of patients with epithelial ovarian cancer (EOC). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- How many people
- 1,108 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 28 Feb 2023
- 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: Patients diagnosed with epithelial ovarian cancer between January 2012 and February 2023 were recruited from seven tertiary medical centers in the China Real World Gynecological Oncology Platform (NUWA).
Who may be able to join
- histologically confirmed primary epithelial ovarian, peritoneal, and fallopian tube cancers.
- patients received comprehensive staged surgery or debulking surgery.
- available data of laboratory examination within 7 days before the surgery.
Who cannot join
- borderline ovarian tumor.
- receipt of neoadjuvant chemotherapy.
- presence of other conditions influencing laboratory data, like hepatitis, kidney disease, autoimmune diseases, infectious diseases, blood disease, etc.
- concurrent cancer in other organs.
- absence of surgery or biopsy only.
- multiple staged surgeries.
About this study
Official title: Influence of Nutritional Risk Indexes and Inflammatory Indicators on Postoperative Complications and Prognosis of Epithelial Ovarian Cancer and Construction of Prediction Models
The goal of this observational study is to explore the influence and predictive significance of nutritional risk indicators and inflammatory indicators on postoperative complications and prognosis of patients with epithelial ovarian cancer (EOC). The main question it aims to answer is:
Can preoperative nutritional risk and inflammatory indexes predict postoperative complications? Do preoperative nutritional risk and inflammatory indexes better predict the prognosis of patients with epithelial ovarian cancer? Which index is the best predictor of postoperative complications or prognosis for patients?
- Conditions
- Epithelial Ovarian Cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial
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 |
|---|---|---|
| Low [index] group | The patients were grouped according to the cut-off value of each index, and the patients whose index value was lower than the cut-off value were classified as the Low [index] group. | |
| High [index] group | The patients were grouped according to the cut-off value of each index, and the patients whose index value was higher than the cut-off value were classified as the High [index] group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications
Surgical complications within 30 days after comprehensive staging or cytoreductive surgery recorded according to the Clavien-Dindo grading system
Measured: Within 30 days after surgery
Progression-free survival
Interval between first diagnosis and first recurrence, death, or last follow-up
Measured: From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of disease progression or death or last follow-up, whichever occurred first, assessed up to 100 months.
Overall survival
Interval between first diagnosis and death, or last follow-up
Measured: From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of death or last follow-up, whichever occurred first, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2012
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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 Epithelial 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qinglei Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483399
- Sponsor's protocol ID
- 2024-TJ-NIOC
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Li M, Zhao Y, Jiao X, Yu Y, Li R, Zeng S, Chi J, Ma G, Huo Y, Peng Z, Liu J, Zhou Q, Zou D, Wang L, Li Q, Wang J, Yao S, Chen Y, Ma D, Hu T, Gao Q. The impact of preoperative immunonutritional status on postoperative complications in ovarian cancer. J Ovarian Res. 2025 Apr 29;18(1):88. doi: 10.1186/s13048-025-01624-3.
PubMed 40301987
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nutritional Risk Indexes and Inflammatory Indicators on Postoperative Complications and Prognosis of Epithelial Ovarian Cancer and Construction of Prediction Models
- ClinicalTrials.gov ID
- NCT06483399
- Acronym / sponsor ID
- 2024-TJ-NIOC
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,108 participants (actual)
- Lead sponsor
- Qinglei GaoUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 3 Jul 2024 (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.
The goal of this observational study is to explore the influence and predictive significance of nutritional risk indicators and inflammatory indicators on postoperative complications and prognosis of patients with epithelial ovarian cancer (EOC). The main question it aims to answer is:
Can preoperative nutritional risk and inflammatory indexes predict postoperative complications? Do preoperative nutritional risk and inflammatory indexes better predict the prognosis of patients with epithelial ovarian cancer? Which index is the best predictor of postoperative complications or prognosis for patients?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low [index] group | – | –The patients were grouped according to the cut-off value of each index, and the patients whose index value was lower than the cut-off value were classified as the Low [index] group. |
| High [index] group | – | –The patients were grouped according to the cut-off value of each index, and the patients whose index value was higher than the cut-off value were classified as the High [index] group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with epithelial ovarian cancer between January 2012 and February 2023 were recruited from seven tertiary medical centers in the China Real World Gynecological Oncology Platform (NUWA).
Key inclusion criteria (3 listed)
- histologically confirmed primary epithelial ovarian, peritoneal, and fallopian tube cancers.
- patients received comprehensive staged surgery or debulking surgery.
- available data of laboratory examination within 7 days before the surgery.
Key exclusion criteria (6 listed)
- borderline ovarian tumor.
- receipt of neoadjuvant chemotherapy.
- presence of other conditions influencing laboratory data, like hepatitis, kidney disease, autoimmune diseases, infectious diseases, blood disease, etc.
- concurrent cancer in other organs.
- absence of surgery or biopsy only.
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
Postoperative Complications
Time frame: Within 30 days after surgery
Surgical complications within 30 days after comprehensive staging or cytoreductive surgery recorded according to the Clavien-Dindo grading system
Progression-free survival
Time frame: From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of disease progression or death or last follow-up, whichever occurred first, assessed up to 100 months.
Interval between first diagnosis and first recurrence, death, or last follow-up
Overall survival
Time frame: From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of death or last follow-up, whichever occurred first, assessed up to 100 months.
Interval between first diagnosis and death, or last follow-up
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 3 Jul 2024.
- Derived from this study: PubMed 40301987Liu X, Li M, Zhao Y, Jiao X, Yu Y, Li R, Zeng S, Chi J, Ma G, Huo Y, Peng Z, Liu J, Zhou Q, Zou D, Wang L, Li Q, Wang J, Yao S, Chen Y, Ma D, Hu T, Gao Q. The impact of preoperative immunonutritional status on postoperative complications in ovarian cancer. J Ovarian Res. 2025 Apr 29;18(1):88. doi: 10.1186/s13048-025-01624-3.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, run by Qinglei Gao.
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 6 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative Complications (time frame: Within 30 days after surgery). The study lists 3 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 NCT06483399, 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 3 Jul 2024.