Quality of Life in Thai Women Diagnosed Cervical Cancer a... | NCT00741533

Studies
Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital

NCT00741533

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Nov 18, 2010Estimated

Enrollment

172Actual

Phase

Not provided

Conditions

Quality of Life
Cervical Cancer
Cervical Intraepithelial Neoplasia

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

Feb 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Jul 2009Actual

First Submitted Date

Aug 25, 2008

First Submission Date that Met QC Criteria

Aug 25, 2008

First Posted Date

Aug 26, 2008Estimated

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 17, 2010

Last Update Posted Date

Nov 18, 2010Estimated

Name	Class
Merck Sharp & Dohme LLC	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

Description Module

Brief Summary

To study the quality of life of patients earlier diagnosed for cervical cancer and cervical intraepithelial neoplasia (CIN).

Detailed Description

In Thailand, age standardized incidence is 20.9 per 100,000 women-year. Treatment-related survival gain are experienced by side-effect that may reduce quality of life (QoL). We therefore, study the quality of life of patients earlier diagnosed for cervical cancer patients.

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

172Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Thai patients
aged more than 15 years old.
Diagnosed of cervical intraepithelial neoplasia (CIN) or cervical cancer with pathological confirmation. If she has more than one diseases, the most severe will be considered as diagnosis.
Not suffered from confusion or reduced level of consciousness or unable to communicate.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Cervical intraepithelial neoplasia (CIN) or cervical cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Surasak Taneepanichskul, MD.	College of Public Health Sciences, Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Chulalongkorn Memorial Hospital		Patumwan	Bangkok	10330	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D002578	Uterine Cervical Dysplasia

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided