Characteristics of Patients With Thymoma in Chulalongkorn... | NCT01123590

Studies
Characteristics of Patients With Thymoma in Chulalongkorn Hospital

NCT01123590

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Nov 23, 2010Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Thymoma Staging
Clinical Presentations
Associated Disorders
Laboratory Findings

Interventions

Not provided

Countries

Thailand

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

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

May 12, 2010

First Submission Date that Met QC Criteria

May 13, 2010

First Posted Date

May 14, 2010Estimated

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

Nov 21, 2010

Last Update Posted Date

Nov 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to study characteristics of patients with thymoma in Chulalongkorn hospital between 2003-2007.

Detailed Description

To study characteristics of patients with thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007 in terms of clinical manifestations, associated diseases, and laboratory findings.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thymoma		Patients with thymoma
Control		Normal controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thymoma staging and clinical manifestations		5 years

Secondary Outcomes

Measure	Description	Time Frame
Associated diseases and laboratory findings Immunological data		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histocytological proved thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

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

Patients with thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jettanong Klaewsongkram, MD	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Chulalongkorn University		Bangkok		10330	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23229679	Derived	Thongprayoon C, Tantrachoti P, Phatharacharukul P, Buranapraditkun S, Klaewsongkram J. Associated immunological disorders and cellular immune dysfunction in thymoma: a study of 87 cases from Thailand. Arch Immunol Ther Exp (Warsz). 2013 Feb;61(1):85-93. doi: 10.1007/s00005-012-0207-9. Epub 2012 Dec 11.

ID	Term
D013945	Thymoma
D001327	Autoimmune Diseases
D007153	Immunologic Deficiency Syndromes

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D013953	Thymus Neoplasms