NCT03932058

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 26, 2019

Last Update Submit

April 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • proteomics changes

    Study of changes in proteomes in tumor cells by high-throughput proteomics analysis

    2 years

Study Arms (3)

osteosarcoma

Drug: Chemotherapy

chondrosarcoma

enchondroma

Interventions

all osteosarcoma patients will give regular chemotherapy for osteosarcoma, the protocol is the same as Methotrexate+Doxorubicin+Cisplatin.

osteosarcoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

  • non-chemotherapy patients
  • bio-specimen not completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310020, China

RECRUITING

MeSH Terms

Conditions

Osteosarcoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • zhaoming Ye, Prof.

    2nd Affiliated Hospital Of Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2019

First Posted

April 30, 2019

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

May 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations