Molecular Markers in Cervical Cancer Screening in the Fea... | NCT00889902

Studies
Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis

NCT00889902

Sponsor

Wuhan University

Status

Unknown status

Last Update Posted

Apr 29, 2009Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Not provided

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 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Jul 2011Estimated

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 27, 2009

First Posted Date

Apr 29, 2009Estimated

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 27, 2009

Last Update Posted Date

Apr 29, 2009Estimated

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:

make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer.
reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.

Detailed Description

To carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers Detect + P16INK4A" methods of screening accuracy and reliability, as well as the screening method of the biological effects.
Markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. With a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.

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

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Married women aged 25 to 65-year-old with risk factors
No tumor and pelvic radiation therapy history
Non-pregnant women at present

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

residents of a certain town

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hong B Cai, Doctor	Contact	0086-027-67813044		Chb2105@163.com
Ying J Huang	Contact

Overall Officials

Name	Affiliation	Role
Hong B Cai, Doctor	gynecologic oncology department, Zhongnan Hospital of Wuhan University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
People'S Hospital		Wufeng County	Hubei		China

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

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