Cancer Genome Analysis | NCT01458704

Studies
Cancer Genome Analysis

NCT01458704

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Oct 25, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Malignant Tumor

Interventions

next generation sequencing

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 2011

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

Aug 2011

Primary Completion Date

Apr 2013Estimated

Completion Date

Not provided

First Submitted Date

Oct 23, 2011

First Submission Date that Met QC Criteria

Oct 24, 2011

First Posted Date

Oct 25, 2011Estimated

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 24, 2011

Last Update Posted Date

Oct 25, 2011Estimated

Description Module

Brief Summary

Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome sequencing) will be performed from fresh frozen tumor samples to understand the genetic alteration of tumors and to aid in optimal selection of further therapeutic agents.

Detailed Description

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

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fresh frozen tumor tissue		patients providing fresh frozen tumor tissue	Other: next generation sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
next generation sequencing	Other	next generation sequencing (including targeted gene sequencing, exome sequencing, transcriptome sequenicing)	fresh frozen tumor tissue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
targeted sequencing of cancer-relate genes	Identification and characterization of genetic alteration in cancer tissue	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with malignant tumor
receiving or planning to receive chemotherapy
with fresh frozen tumor tissue
with informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with malignant tumor receiving or planning to receive chemotherapy with fresh frozen tumor tissue with informed consent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae-You Kim	Contact	82-2-2072-2228

Overall Officials

Name	Affiliation	Role
Tae-You Kim	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
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059014	High-Throughput Nucleotide Sequencing

Ancestor Terms

ID	Term
D017421	Sequence Analysis
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided