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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Proteomics Research of Osteosarcoma

Clinicaltrials.gov identifier NCT03932058

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted May 2, 2019

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:Osteosarcoma
    Proteomics
  • Intervention/Treatment: Drug: Chemotherapy
  • Phase: N/A
Detailed Description

N/A

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 2018
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: September 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: osteosarcoma
Drug: Chemotherapy
all osteosarcoma patients will give regular chemotherapy for osteosarcoma, the protocol is the same as Methotrexate+Doxorubicin+Cisplatin.
Outcome Measures
  • Primary Outcome Measures: 1. 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
Hangzhou

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Principal Investigator: zhaoming Ye, Prof. 2nd Affiliated Hospital Of Zhejiang University

More Information
  • Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
  • ClinicalTrials.gov Identifier: NCT03932058 History of Changes
  • Other Study ID Numbers: PR-OS-001
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: May 2, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Osteosarcoma