Renal Cell Carcinoma, Clear CellNCT06656039
A Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma, Clear Cell, run by RenJi Hospital at 1 site in China.
Trial summary
The main goal of this observational study is to construct a predictive recurrence model for renal clear cell carcinoma through an artificial intelligence multimodal algorithm, which will improve the prognosis and survival time of ccRCC patients by helping clinicians to formulate individualised follow-up and to screen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Clear Cell
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 10 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathologically confirmed postoperative patients with renal clear cell carcinoma of TNM stage I-III
Who may be able to join
- Patients with malignant renal tumours must have postoperative pathological confirmation of renal clear cell carcinoma with pathological TNM stage Ⅰ-Ⅲ;
- Have available preoperative imaging
- Have available post-operative pathological paraffin samples or HE-stained tissue sections
- Must agree to and be able to comply with the study's visit schedule and other requirements as specified in the protocol, including follow-up visits by telephone
Who cannot join
- The patient's tumour type cannot be determined on the basis of histopathological sections
- Simultaneous combination of primary tumours at other sites;
- No regular follow-up imaging data
- Cases in which other factors led the investigator to believe that enrolment was inappropriate
- Cases that met all the inclusion criteria of the appeal and did not meet all the exclusion criteria were selected for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma: a Multicenter Cohort Study
The main goal of this observational study is to construct a predictive recurrence model for renal clear cell carcinoma through an artificial intelligence multimodal algorithm, which will improve the prognosis and survival time of ccRCC patients by helping clinicians to formulate individualised follow-up and to screen for appropriate adjuvant therapy candidates.
- Conditions
- Renal Cell Carcinoma, Clear Cell
- Keywords
- Renal Cell Carcinoma, Multimodal, Artificial Intelligence, Prognosis, Deep Learning, Multicentre Study
- Medical subject headings
- Carcinoma, Renal Cell
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 |
|---|---|---|
| Training cohort | Not described | |
| Validation cohort | Not described | |
| Test cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Defined as from surgery to tumor recurrence or follow-up deadline
Measured: "Baseline, immediately after the surgery", "Tumour recurrence or further follow-up", "Three months after surgery", "Six months after surgery", "Every year after surgery, at least follow-up 2years, up to 10 years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Jan 2024
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma, Clear CellStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Fourth Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Soochow University, Qianfoshan Hospital, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656039
- Sponsor's protocol ID
- ccRCC MRPS
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to interested research partners upon reasonable request to Zhaiwei or Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; the prerequisite for this is a data transfer agreement, approved by the legal departments of the requesting researcher and by all legal departments of the institutions that provided data for the study, and an ethics clearance.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06656039
- Acronym / sponsor ID
- ccRCC MRPS
- Conditions
- Renal Cell Carcinoma, Clear Cell
- Keywords
- Renal Cell Carcinoma, Multimodal, Artificial Intelligence, Prognosis, Deep Learning, Multicentre Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Fourth Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Soochow University, Qianfoshan Hospital, Chang Gung Memorial Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 24 Oct 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 main goal of this observational study is to construct a predictive recurrence model for renal clear cell carcinoma through an artificial intelligence multimodal algorithm, which will improve the prognosis and survival time of ccRCC patients by helping clinicians to formulate individualised follow-up and to screen for appropriate adjuvant therapy candidates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | – |
| Validation cohort | – | – |
| Test cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically confirmed postoperative patients with renal clear cell carcinoma of TNM stage I-III
Key inclusion criteria (4 listed)
- Patients with malignant renal tumours must have postoperative pathological confirmation of renal clear cell carcinoma with pathological TNM stage Ⅰ-Ⅲ;
- Have available preoperative imaging
- Have available post-operative pathological paraffin samples or HE-stained tissue sections
- Must agree to and be able to comply with the study's visit schedule and other requirements as specified in the protocol, including follow-up visits by telephone
Key exclusion criteria (5 listed)
- The patient's tumour type cannot be determined on the basis of histopathological sections
- Simultaneous combination of primary tumours at other sites;
- No regular follow-up imaging data
- Cases in which other factors led the investigator to believe that enrolment was inappropriate
- Cases that met all the inclusion criteria of the appeal and did not meet all the exclusion criteria were selected for this study
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
Disease free survival
Time frame: "Baseline, immediately after the surgery", "Tumour recurrence or further follow-up", "Three months after surgery", "Six months after surgery", "Every year after surgery, at least follow-up 2years, up to 10 years"
Defined as from surgery to tumor recurrence or follow-up deadline
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 24 Oct 2024.
- Individual participant dataSharing planned: Yes. Data will be made available to interested research partners upon reasonable request to Zhaiwei or Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; the prerequisite for this is a data transfer agreement, approved by the legal departments of the requesting researcher and by all legal departments of the institutions that provided data for the study, and an ethics clearance.
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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 Renal Cell Carcinoma, Clear Cell, run by RenJi Hospital 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 5 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 24 Oct 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?
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?
Disease free survival (time frame: "Baseline, immediately after the surgery", "Tumour recurrence or further follow-up", "Three months after surgery", "Six months after surgery", "Every year after surgery, at least follow-up 2years, up to 10 years"). 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 24 Oct 2024.