High-grade Serous Ovarian Cancer (HGSOC)PPRPHGSOCNCT06787170
Prediction of Platinum Resistance and Prognosis of High-grade Serous Ovarian Cancer
An observational study of High-grade Serous Ovarian Cancer (HGSOC), run by The First People's Hospital of Yunnan at 1 site in China.
Trial summary
High-grade serous ovarian carcinoma (HGSOC) is the most common subtype of ovarian carcinoma. Platinum-based drugs are the first-line chemotherapeutic agents for HGSOC, but platinum resistance and prognosis are difficult to predict. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- High-grade Serous Ovarian Cancer (HGSOC)
- What is being tested?
- MRI habitat imaging
- How many people
- 1,129 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 May 2024
- 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: HGSOC patients confirmed by surgery and pathology
Who may be able to join
- Patients diagnosed as HGSOC based on surgery and pathology.
- The standard treatment including surgical cytoreduction followed by at least three cycles of regular platinum-based chemotherapy after surgery.
- Follow-up records available for more than six months after postoperative chemotherapy.
- For MRI analysis, pelvic MRI examination including axial T2-weighted imaging (T2WI), contrast-enhanced T1-weighted imaging (CE-T1WI), and diffusion-weighted imaging (DWI) was performed within two weeks prior to treatment, and patients had no any treatments other than neoadjuvant chemotherapy (NACT) performed between MRI and surgery.
Who cannot join
- Patients with a history of platinum-based chemotherapy for other malignancies.
- Absence of essential clinical data.
- For MRI analysis, patients with poor MRI imaging quality and registration, or a tumor maximum diameter < 1 cm on MRI needed to be excluded.
- For pathology analysis, patients without H\&E-stained WSIs or with poor WSI imaging quality should be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
the First People's Hospital of Yunnan Province
Kunming, Yunnan, 400016
About this study
Official title: Prediction of Platinum Resistance and Prognosis in Patients with High-grade Serous Ovarian Cancer Based on MRI Habitat Imaging and Radiopathomics
High-grade serous ovarian carcinoma (HGSOC) is the most common subtype of ovarian carcinoma. Platinum-based drugs are the first-line chemotherapeutic agents for HGSOC, but platinum resistance and prognosis are difficult to predict. Domestic and foreign studies have found that multi-functional MRI could reflect the macroscopic heterogeneity of tumors from different perspectives; habitat imaging contributed to reflecting the spatial heterogeneity of tumors; the attention mechanism could integrate features of different scales; and multi-omics were capable to improve predictive performance. Previously, our team has demonstrated the importance of MRI and its functional imaging in the diagnosis and histological evaluation of gynecological tumors. And conventional MRI habitat imaging, multi-instance learning based on whole slide image (WSI), and multi-omics model could effectively predict platinum resistance in HGSOC patients. Therefore, this study aims to perform habitat imaging on multi-functional MRI such as multi b-value DWI and DCE-MRI and to train WSI-based multi-instance learning to construct pathological signature. Then, combined with clinical indicators, radiomics based on MRI habitat, and pathomics, a multi-omics fusion model trained by attention mechanism was constructed. Finally, to explore the value of MRI habitat, WSI, and multi-omics in predicting platinum resistance and prognosis in HGSOC patients. This study combines macroscopic functional imaging and microscopic pathological information to construct a multi-omics complementary model, which can predict platinum resistance and prognosis of HGSOC patients more comprehensively and accurately, and further guide the formulation of clinical treatment.
- Conditions
- High-grade Serous Ovarian Cancer (HGSOC)
- Being tested
- MRI habitat imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI habitat imagingDiagnostic test
Also called radiopathomics
Habitat imaging, a data-driven image processing technique that divides the entire lesion into multiple sub-regions without assuming anything prior, has capacity to noninvasively evaluate the intratumoral heterogeneity.
What is being measured
The primary outcome is the main question the study is designed to answer.
platinum resistance
Platinum resistance is determined based on whether there is disease progression during or within 6 months after termination of platinum-based chemotherapy.
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Nov 2022
- Primary completion1 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Serous Ovarian Cancer (HGSOC)Studies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Yunnan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Bi, The First People's Hospital of Yunnan
- Investigators
- Qiu Bi, Principal investigator, The First People's Hospital of Yunnan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787170
- Sponsor's protocol ID
- KHLL2023-KY208
- Other IDs
- 82460340
- Acronym
- PPRPHGSOC
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 23 Jan 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Platinum Resistance and Prognosis in Patients with High-grade Serous Ovarian Cancer Based on MRI Habitat Imaging and Radiopathomics
- ClinicalTrials.gov ID
- NCT06787170
- Acronym / sponsor ID
- PPRPHGSOC / KHLL2023-KY208
- Conditions
- High-grade Serous Ovarian Cancer (HGSOC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- The First People's Hospital of YunnanUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 22 Jan 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.
High-grade serous ovarian carcinoma (HGSOC) is the most common subtype of ovarian carcinoma. Platinum-based drugs are the first-line chemotherapeutic agents for HGSOC, but platinum resistance and prognosis are difficult to predict. Domestic and foreign studies have found that multi-functional MRI could reflect the macroscopic heterogeneity of tumors from different perspectives; habitat imaging contributed to reflecting the spatial heterogeneity of tumors; the attention mechanism could integrate features of different scales; and multi-omics were capable to improve predictive performance. Previously, our team has demonstrated the importance of MRI and its functional imaging in the diagnosis and histological evaluation of gynecological tumors. And conventional MRI habitat imaging, multi-instance learning based on whole slide image (WSI), and multi-omics model could effectively predict platinum resistance in HGSOC patients. Therefore, this study aims to perform habitat imaging on multi-functional MRI such as multi b-value DWI and DCE-MRI and to train WSI-based multi-instance learning to construct pathological signature. Then, combined with clinical indicators, radiomics based on MRI habitat, and pathomics, a multi-omics fusion model trained by attention mechanism was constructed. Finally, to explore the value of MRI habitat, WSI, and multi-omics in predicting platinum resistance and prognosis in HGSOC patients. This study combines macroscopic functional imaging and microscopic pathological information to construct a multi-omics complementary model, which can predict platinum resistance and prognosis of HGSOC patients more comprehensively and accurately, and further guide the formulation of clinical treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HGSOC patients confirmed by surgery and pathology
Key inclusion criteria (4 listed)
- Patients diagnosed as HGSOC based on surgery and pathology.
- The standard treatment including surgical cytoreduction followed by at least three cycles of regular platinum-based chemotherapy after surgery.
- Follow-up records available for more than six months after postoperative chemotherapy.
- For MRI analysis, pelvic MRI examination including axial T2-weighted imaging (T2WI), contrast-enhanced T1-weighted imaging (CE-T1WI), and diffusion-weighted imaging (DWI) was performed within two weeks prior to treatment, and patients had no any treatments other than neoadjuvant chemotherapy (NACT) performed between MRI and surgery.
Key exclusion criteria (4 listed)
- Patients with a history of platinum-based chemotherapy for other malignancies.
- Absence of essential clinical data.
- For MRI analysis, patients with poor MRI imaging quality and registration, or a tumor maximum diameter < 1 cm on MRI needed to be excluded.
- For pathology analysis, patients without H\&E-stained WSIs or with poor WSI imaging quality should be excluded.
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 |
|---|---|---|
| MRI habitat imagingAlso: radiopathomicsHabitat imaging, a data-driven image processing technique that divides the entire lesion into multiple sub-regions without assuming anything prior, has capacity to noninvasively evaluate the intratumoral heterogeneity. | Diagnostic test | – |
Primary outcome
platinum resistance
Time frame: within 6 months
Platinum resistance is determined based on whether there is disease progression during or within 6 months after termination of platinum-based chemotherapy.
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 Jan 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.
Qiu Bi principal investigator
The First People's Hospital of Yunnan
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 High-grade Serous Ovarian Cancer (HGSOC), run by The First People's Hospital of Yunnan 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 4 inclusion and 4 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 Jan 2025. 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?
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?
platinum resistance (time frame: within 6 months). 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 Jan 2025.