Establishing Effective Screening Methods for Diagnosing H... | NCT00516230

Studies
Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer

NCT00516230

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Aug 15, 2007Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Colonic Neoplasms

Interventions

Not provided

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

Aug 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

Jan 2006

Primary Completion Date

Not provided

Completion Date

Dec 2011Estimated

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 15, 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

Aug 13, 2007

Last Update Posted Date

Aug 15, 2007Estimated

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

Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.

Detailed Description

Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).

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

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colorectal cancer

Exclusion Criteria:

Histology showing other than adenocarcinoma

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Kyung Chang, M.D. Ph.D	Contact	+82-2-3410-3409		dkchang@skku.edu
Tae Kuen Kim	Contact	+82-2-3410-2975		tggo.kim@samsung.com

Overall Officials

Name	Affiliation	Role
Dong Kyung Chang, M.D. Ph.D	Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul	Gangnam-gu	135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D003123	Colorectal Neoplasms, Hereditary Nonpolyposis

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided