Observational Study of Anti-Cancer Therapy Induced Oral M... | NCT00549952

Studies
Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients

NCT00549952

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Oct 26, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Oral Mucositis

Interventions

no intervention study

Countries

South Korea

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

Oct 2007

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

Oct 2007

Primary Completion Date

Not provided

Completion Date

Mar 2008Estimated

First Submitted Date

Oct 25, 2007

First Submission Date that Met QC Criteria

Oct 25, 2007

First Posted Date

Oct 26, 2007Estimated

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

Oct 25, 2007

Last Update Posted Date

Oct 26, 2007Estimated

Name	Class
Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
no intervention study	Other

Measure	Description	Time Frame
incidence and severity of oral mucositis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with one cancer among head and neck cancer, esophageal cancer, breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, who are being treated or going to be treated as one between A and B A. Chemotherapy only B. Concurrent chemoradiotherapy

Exclusion Criteria:

Patients who are pregnant or breast feeding, absent from effective(medically proven) contraceptive method for females of childbearing potential
Patients with performance status of ECOG score is more than 3

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yonghui Jeong	Contact	82-2-3465-3956		jeongyh@otsuka.co.kr
Boyoun Seo	Contact	82-2-3465-5485		byseo@otsuka.cokr

Overall Officials

Name	Affiliation	Role
Do-Youn Oh, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University hospital	Recruiting	Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013280	Stomatitis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided