Proteomics Research of Osteosarcoma | NCT03932058

Studies
Proteomics Research of Osteosarcoma

NCT03932058

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

May 2, 2019Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Osteosarcoma
Proteomics

Interventions

Chemotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Sep 1, 2019Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

Apr 26, 2019

First Posted Date

Apr 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2019

Last Update Posted Date

May 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhaoming Ye, Professor, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
osteosarcoma			Drug: Chemotherapy
chondrosarcoma
enchondroma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chemotherapy	Drug	all osteosarcoma patients will give regular chemotherapy for osteosarcoma, the protocol is the same as Methotrexate+Doxorubicin+Cisplatin.	osteosarcoma

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

non-chemotherapy patients
bio-specimen not completed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
zhan Wang, Dr.	Contact	+8618758586092		wangzhan515@yahoo.com
Xiaobo Yan	Contact	+8613588153306		yanxiaobo82@gmail.com

Overall Officials

Name	Affiliation	Role
zhaoming Ye, Prof.	2nd Affiliated Hospital Of Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital of Zhejiang University	Recruiting	Hangzhou	Zhejiang	310020	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012516	Osteosarcoma

Ancestor Terms

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided