Comparison Between ex Vivo and in Vivo Injection of Blue... | NCT00654342

Studies
Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

NCT00654342

Sponsor

Chung-Ang University

Status

Unknown status

Last Update Posted

Apr 8, 2008Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Sentinel Lymph Node Biopsy
Colon Cancer

Interventions

Intraoperative injection (in vivo)
Postoperative injection (ex vivo)

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

Apr 2008

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

Feb 2009Estimated

Completion Date

Not provided

First Submitted Date

Apr 2, 2008

First Submission Date that Met QC Criteria

Apr 2, 2008

First Posted Date

Apr 8, 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

Apr 2, 2008

Last Update Posted Date

Apr 8, 2008Estimated

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

The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	In vivo injection group	Procedure: Intraoperative injection (in vivo)
2	Other	Ex vivo injection group	Procedure: Postoperative injection (ex vivo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraoperative injection (in vivo)	Procedure	Intraoperative injection	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy & sensitivity of sentinel lymph node mapping		After confirmed pathological report

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage I - III colon cancer patients

Exclusion Criteria:

cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
In-Taik Chang, M.D., Ph.D.	Contact	82-2-6299-1562		caumed5@naver.com
Jun Seok Park, M.D.	Contact	82-2-6299-1548		doctorsupreme@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Chung-Ang university Hospital	Recruiting	Seoul		156-755	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

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

Intervention Browse Module

MeSH Terms

ID	Term
D011184	Postoperative Period

Ancestor Terms

ID	Term
D059035	Perioperative Period
D013514	Surgical Procedures, Operative
D005791	Patient Care
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided