Proteomics Research of Osteosarcoma (PROS001)

April 30, 2019 updated by: Zhaoming Ye, Second Affiliated Hospital, School of Medicine, Zhejiang University

Establishment of New Molecular Prototyping Based on Proteomics for Predicting Osteosarcoma Chemotherapy Response and Risk of Recurrence

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310020
        • Recruiting
        • 2nd Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • all osteosarcoma patients in our hospital
  • received Methotrexate+Doxorubicin+Cisplatin protocol chemotherapy

Exclusion Criteria:

  • non-chemotherapy patients
  • bio-specimen not completed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proteomics changes
Time Frame: 2 years
Study of changes in proteomes in tumor cells by high-throughput proteomics analysis
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (ACTUAL)

April 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-OS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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