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出境医 / 临床实验 / Proteomics Research of Osteosarcoma (PROS001)
Proteomics Research of Osteosarcoma (PROS001)
Study Description
Brief Summary:
Retrospectively collected 400 cases of clinical data and pathological paraffin specimens of osteosarcoma, chondrosarcoma (control) and endogenous chondroma (control) in our hospital from 2008 to 2014, combined with high-pressure cycle-satellite scanning mass spectrometry (PCT-SWATH) Molecular typing of osteosarcoma and prediction of targeted therapy, the establishment of a new molecular classification based on proteomics for osteosarcoma to predict the chemotherapy response and recurrence risk of osteosarcoma. Clinical osteosarcoma patients include as many types as possible: pre-chemotherapy, post-chemotherapy, recurrence, and metastasis. The study did not involve vulnerable groups, and it was taken as a postoperative wax specimen for patients, which had no health, life and other effects on patients. Study application exemption from informed consent.
| Condition or disease | Intervention/treatment |
|---|---|
| Osteosarcoma Proteomics | Drug: Chemotherapy |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Establishment of New Molecular Prototyping Based on Proteomics for Predicting Osteosarcoma Chemotherapy Response and Risk of Recurrence |
| Actual Study Start Date : | September 1, 2018 |
| Estimated Primary Completion Date : | September 1, 2019 |
| Estimated Study Completion Date : | September 1, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| osteosarcoma |
Drug: Chemotherapy
all osteosarcoma patients will give regular chemotherapy for osteosarcoma, the protocol is the same as Methotrexate+Doxorubicin+Cisplatin.
|
| chondrosarcoma | |
| enchondroma |
Outcome Measures
Primary Outcome Measures :
- proteomics changes [ Time Frame: 2 years ]Study of changes in proteomes in tumor cells by high-throughput proteomics analysis
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
primary care clinic
Criteria
Inclusion Criteria:
- all osteosarcoma patients in our hospital
- received Methotrexate+Doxorubicin+Cisplatin protocol chemotherapy
Exclusion Criteria:
- non-chemotherapy patients
- bio-specimen not completed
Contacts and Locations
Contacts
| Contact: zhan Wang, Dr. | +8618758586092 | wangzhan515@yahoo.com | |
| Contact: Xiaobo Yan | +8613588153306 | yanxiaobo82@gmail.com |
Locations
| China, Zhejiang | |
| 2nd Affiliated Hospital of Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China, 310020 | |
| Contact: Xiaobo Yan 13588153306 yanxiaobo82@gmail.com | |
| Principal Investigator: zhaoming Ye, Prof. | |
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
| Principal Investigator: | zhaoming Ye, Prof. | 2nd Affiliated Hospital Of Zhejiang University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 26, 2019 | ||||
| First Posted Date | April 30, 2019 | ||||
| Last Update Posted Date | May 2, 2019 | ||||
| Actual Study Start Date | September 1, 2018 | ||||
| Estimated Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
proteomics changes [ Time Frame: 2 years ] Study of changes in proteomes in tumor cells by high-throughput proteomics analysis
|
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| Original Primary Outcome Measures |
proteomics changes [ Time Frame: 2 years ] | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Proteomics Research of Osteosarcoma | ||||
| Official Title | Establishment of New Molecular Prototyping Based on Proteomics for Predicting Osteosarcoma Chemotherapy Response and Risk of Recurrence | ||||
| Brief Summary | Retrospectively collected 400 cases of clinical data and pathological paraffin specimens of osteosarcoma, chondrosarcoma (control) and endogenous chondroma (control) in our hospital from 2008 to 2014, combined with high-pressure cycle-satellite scanning mass spectrometry (PCT-SWATH) Molecular typing of osteosarcoma and prediction of targeted therapy, the establishment of a new molecular classification based on proteomics for osteosarcoma to predict the chemotherapy response and recurrence risk of osteosarcoma. Clinical osteosarcoma patients include as many types as possible: pre-chemotherapy, post-chemotherapy, recurrence, and metastasis. The study did not involve vulnerable groups, and it was taken as a postoperative wax specimen for patients, which had no health, life and other effects on patients. Study application exemption from informed consent. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | primary care clinic | ||||
| Condition |
|
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| Intervention | Drug: Chemotherapy
all osteosarcoma patients will give regular chemotherapy for osteosarcoma, the protocol is the same as Methotrexate+Doxorubicin+Cisplatin.
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
400 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | September 1, 2020 | ||||
| Estimated Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03932058 | ||||
| Other Study ID Numbers | PR-OS-001 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Study Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Verification Date | April 2019 | ||||
