Ovarian Metastases of Colorectal CancerNCT06192030
Machine Learning Predicts Survival and Mutations in Ovarian Metastases of Colorectal Cancer
An observational study of Ovarian Metastases of Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The study aimed to develop and validate models to predict survival outcome and key mutations in patients with ovarian metastases of colorectal cancer, as well as to compare the differential gene expression between long-survival group and short-survival group. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Ovarian Metastases of Colorectal Cancer
- What is being tested?
- Prediction model
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2022to Aug 2025
- 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 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ovarian metastases from colorectal cancer
Who may be able to join
- Histologically confirmed colorectal cancer
- Unilateral or bilateral ovarian masses confirmed by peroperative imaging examination
- Patient requiring resection of their ovarian and/or peritoneal carcinomatosis
- 18 ≤ Age ≤ 85
- World Health Organization performance status ≤ 1
- Life expectancy > 12 weeks
- Adequate haematological, liver and renal function
- Patient information and signature of the informed consent form before the start of any treatment procedures
Who cannot join
- Ovarian metastases of origin other than colorectal
- Primary ovarian tumor
- Clinical data missing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Huaiming Wang, MD, wanghm7@mail.sysu.edu.cn
Huaiming Wang, MD
About this study
Official title: Machine Learning-based Model for Prediction of Survival and Mutations in Ovarian Metastases of Colorectal Cancer
The study aimed to develop and validate models to predict survival outcome and key mutations in patients with ovarian metastases of colorectal cancer, as well as to compare the differential gene expression between long-survival group and short-survival group.
Read the detailed description
The investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict survival outcome and key mutations from multimodality data in patients with ovarian metastases of colorectal cancer. Secondly, the investigator aimed to compare the differential gene expression between long-survival group and short-survival group.
- Conditions
- Ovarian Metastases of Colorectal Cancer
- Being tested
- Prediction model
- Keywords
- Krukenberg tumor
- Medical subject headings
- Krukenberg Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction modelOther
We develop and validate clinical models to predict patient survival and gene signatures in ovarian metastases of colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | The cohort was retrospectively enrolled in The Sixth Affiliated Hospital, Sun Yat-sen University from August 2010 to August 2022. It is a training cohort. Receives: Other: Prediction model | |
| Prospective cohort | The same inclusion/exclusion criteria were applied for the same center prospectively. It is a validation cohort. Receives: Other: Prediction model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival was defined as the time from surgery to death, or to the last follow-up.
Measured: At least 3-year follow up
Disease-free survival
Disease-free survival was defined as the interval between surgery and the first peritoneal or distant relapse or death from any cause.
Measured: At least 1-year follow up
Peritoneal-free survival
Peritoneal-free survival was defined as the interval between surgery and the first peritoneal relapse. Ovarian metastasis has been shown to be a subtype of peritoneal metastasis.
Measured: At least 1-year follow up
Secondary outcomes (1)
Rates of key gene mutation
Rates of key gene mutation, such as microsatellite instability-high/DNA mismatch repair
Measured: At least 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start27 Aug 2022
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Metastases of Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192030
- Sponsor's protocol ID
- wanghm7
- Status last verified
- Jan 2024
- First submitted
- 9 Oct 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-based Model for Prediction of Survival and Mutations in Ovarian Metastases of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06192030
- Acronym / sponsor ID
- wanghm7
- Conditions
- Ovarian Metastases of Colorectal Cancer
- Keywords
- Krukenberg tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Aug 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 Jan 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 study aimed to develop and validate models to predict survival outcome and key mutations in patients with ovarian metastases of colorectal cancer, as well as to compare the differential gene expression between long-survival group and short-survival group.
Detailed description
The investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict survival outcome and key mutations from multimodality data in patients with ovarian metastases of colorectal cancer. Secondly, the investigator aimed to compare the differential gene expression between long-survival group and short-survival group.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: Prediction modelThe cohort was retrospectively enrolled in The Sixth Affiliated Hospital, Sun Yat-sen University from August 2010 to August 2022. It is a training cohort. |
| Prospective cohort | – | Other: Prediction modelThe same inclusion/exclusion criteria were applied for the same center prospectively. It is a validation cohort. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian metastases from colorectal cancer
Key inclusion criteria (8 listed)
- Histologically confirmed colorectal cancer
- Unilateral or bilateral ovarian masses confirmed by peroperative imaging examination
- Patient requiring resection of their ovarian and/or peritoneal carcinomatosis
- 18 ≤ Age ≤ 85
- World Health Organization performance status ≤ 1
Key exclusion criteria (3 listed)
- Ovarian metastases of origin other than colorectal
- Primary ovarian tumor
- Clinical data missing
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 |
|---|---|---|
| Prediction modelWe develop and validate clinical models to predict patient survival and gene signatures in ovarian metastases of colorectal cancer. | Other | Prospective cohort, Retrospective cohort |
Primary outcome
Overall survival
Time frame: At least 3-year follow up
Overall survival was defined as the time from surgery to death, or to the last follow-up.
Disease-free survival
Time frame: At least 1-year follow up
Disease-free survival was defined as the interval between surgery and the first peritoneal or distant relapse or death from any cause.
Peritoneal-free survival
Time frame: At least 1-year follow up
Peritoneal-free survival was defined as the interval between surgery and the first peritoneal relapse. Ovarian metastasis has been shown to be a subtype of peritoneal metastasis.
1 secondary outcome
Rates of key gene mutation
Time frame: At least 1-year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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 Metastases of Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 8 inclusion and 3 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 5 Jan 2024. 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 Yuanxin Zhang, MD (8617372001179, zyx163yxdz@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: At least 3-year follow up). 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?
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 5 Jan 2024.