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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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The aim of this study is to construct unimodal and multimodal prediction models for overall survival (OS), progression free survival (PFS), and treatment response (complete response+partial response) of advanced first-line chemotherapy based on the imaging, pathological, and genomic characteristics of patients, and evaluate their predictive efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The method of obtaining overall survival (OS) of patients mainly comes from two channels, forming data cross validation: one is the hospital electronic medical record system extracting patients' death records and follow-up records; The second is for researchers to conduct telephone follow-up to obtain the survival status outside the hospital. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Method for obtaining progression free survival (PFS) of patients: treatment progression time, imaging examination reports, tumor markers, and clinical symptom records in hospital electronic medical records; And the patient follow-up examination data and symptom descriptions collected during the follow-up process. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Xia | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China |
IPD contains sensitive data of patients, and even after past identification processing, there is still a potential risk of privacy leakage. In addition, some informed consent forms did not explicitly include the clause of "IPD external sharing" when signed. If they are shared without the patient's supplementary authorization in the future, it will directly violate ethical approval requirements.
2. There is a lack of clear standards for the ownership and division of responsibilities of the results after data use; Due to improper use of data leading to adverse consequences, it is difficult to clearly define the rights and responsibilities of researchers and data users, and researchers may face unnecessary legal disputes.
In summary, the cautious attitude of researchers towards IPD sharing is essentially the result of seeking a balance between scientific value, ethical responsibility, practical costs, and rights protection.
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| Third Affiliated Hospital, Sun Yat-Sen University |
| OTHER |
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| Treatment response | The method for obtaining the evaluation results of patient treatment response: The core data comes from imaging examination reports and tumor marker detection reports in hospital electronic medical records; The auxiliary data includes patient follow-up information collected during clinical symptom records and follow-up processes. | According to RECIST 1.1 criteria, what needs to be obtained in this section is the evaluation results of whether the patient has achieved complete response (CR) or partial response (PR) during the treatment cycle, up to 18 months. |