Ovarian CancerNCT06853730
Regional Distribution Mapping of Lymph Node Metastasis in Epithelial Ovarian Cancer
An observational study of Ovarian Cancer, run by Xu Huishan.
Trial summary
The goal of this observational study is to investigate the metastatic pathways of lymph node involvement in ovarian cancer patients. The main question it aims to answer is: • What are the sequential patterns of lymph node metastasis in ovarian cancer, and are there specific clinical factors associated with different… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 654 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with epithelial ovarian cancer at the First Affiliated Hospital of Sun Yat-sen University from January 2014 to December 2022 were included in this retrospective study. The inclusion criteria were as follows: i) initial diagnosis and tumor cytoreductive surgery performed at the First Affiliated Hospital of Sun Yat-sen University; ii) confirmed postoperative pathology of epithelial ovarian cancer; iii) available lymph node status; and iv) accessible clinical features, including preoperative ultrasound and blood biochemistry tests. The exclusion criteria were: i) initial diagnosis or surgical treatment conducted at other hospitals; ii) absence of imaging results (CT/PET-CT/MRI) or postoperative pathology results for lymph node status. iii) presence of other cancers; and iv) incomplete medical history
Inclusion Criteria:i) initial diagnosis and tumor cytoreductive surgery performed at the First Affiliated Hospital of Sun Yat-sen University; ii) confirmed postoperative pathology of epithelial ovarian cancer; iii) available lymph node status; and iv) accessible clinical features, including preoperative ultrasound and blood biochemistry tests
Exclusion Criteria: i) initial diagnosis or surgical treatment conducted at other hospitals; ii) absence of imaging results (CT/PET-CT/MRI) or postoperative pathology results for lymph node status. iii) presence of other cancers; and iv) incomplete medical history
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About this study
The goal of this observational study is to investigate the metastatic pathways of lymph node involvement in ovarian cancer patients. The main question it aims to answer is: • What are the sequential patterns of lymph node metastasis in ovarian cancer, and are there specific clinical factors associated with different metastatic pathways? Participants diagnosed with ovarian cancer who have undergone lymphadenectomy as part of their standard treatment will have their postoperative pathological lymph node involvement analyzed. The study will retrospectively collect and analyze patient data, including lymph node metastasis patterns, to identify potential progression routes.
- Conditions
- Ovarian Cancer
- Keywords
- Lymph Node Metastasis
- Medical subject headings
- Ovarian Neoplasms, Lymphatic Metastasis
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 |
|---|---|---|
| Non-metastasis Group | This group consists of ovarian cancer patients without lymph node metastasis. By comparing with the metastasis group, we aim to identify the clinical factors that differentiate patients with and without metastasis. | |
| Metastasis Group | This group includes ovarian cancer patients with lymph node metastasis. We will analyze the clinical characteristics and metastasis pathways of these patients to identify clinical factors associated with metastasis.Based on the clinical factors (such as the location of the primary tumor, stage of cancer, etc.), we further subgroup the metastatic patients (e.g., based on the side of the primary tumor). This analysis aims to explore whether there are specific patterns or pathways of lymph node metastasis in these subgroups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of lymph node metastasis in ovarian cancer patients and its association with clinical factors.
The primary goal of this study is to determine the frequency of lymph node metastasis in patients with ovarian cancer and identify clinical factors associated with the occurrence of metastasis.
Measured: From enrollment to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Jan 2014
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu Huishan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Huishan, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853730
- Sponsor's protocol ID
- SYSU-LNM-OVCA01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Distribution Mapping of Lymph Node Metastasis in Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06853730
- Acronym / sponsor ID
- SYSU-LNM-OVCA01
- Conditions
- Ovarian Cancer
- Keywords
- Lymph Node Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- Xu HuishanUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Mar 2025 (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 investigate the metastatic pathways of lymph node involvement in ovarian cancer patients. The main question it aims to answer is: • What are the sequential patterns of lymph node metastasis in ovarian cancer, and are there specific clinical factors associated with different metastatic pathways? Participants diagnosed with ovarian cancer who have undergone lymphadenectomy as part of their standard treatment will have their postoperative pathological lymph node involvement analyzed. The study will retrospectively collect and analyze patient data, including lymph node metastasis patterns, to identify potential progression routes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-metastasis Group | – | –This group consists of ovarian cancer patients without lymph node metastasis. By comparing with the metastasis group, we aim to identify the clinical factors that differentiate patients with and without metastasis. |
| Metastasis Group | – | –This group includes ovarian cancer patients with lymph node metastasis. We will analyze the clinical characteristics and metastasis pathways of these patients to identify clinical factors associated with metastasis.Based on the clinical factors (such as the location of the primary tumor, stage of cancer, etc.), we further subgroup the metastatic patients (e.g., based on the side of the primary tumor). This analysis aims to explore whether there are specific patterns or pathways of lymph node metastasis in these subgroups. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with epithelial ovarian cancer at the First Affiliated Hospital of Sun Yat-sen University from January 2014 to December 2022 were included in this retrospective study. The inclusion criteria were as follows: i) initial diagnosis and tumor cytoreductive surgery performed at the First Affiliated Hospital of Sun Yat-sen University; ii) confirmed postoperative pathology of epithelial ovarian cancer; iii) available lymph node status; and iv) accessible clinical features, including preoperative ultrasound and blood biochemistry tests. The exclusion criteria were: i) initial diagnosis or surgical treatment conducted at other hospitals; ii) absence of imaging results (CT/PET-CT/MRI) or postoperative pathology results for lymph node status. iii) presence of other cancers; and iv) incomplete medical history
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
The incidence of lymph node metastasis in ovarian cancer patients and its association with clinical factors.
Time frame: From enrollment to 6 months post-surgery
The primary goal of this study is to determine the frequency of lymph node metastasis in patients with ovarian cancer and identify clinical factors associated with the occurrence of metastasis.
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 Mar 2025.
- Individual participant dataSharing planned: No
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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 Ovarian Cancer, run by Xu Huishan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. 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?
The incidence of lymph node metastasis in ovarian cancer patients and its association with clinical factors. (time frame: From enrollment to 6 months post-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 3 Mar 2025.