Biomarker Analysis of Solid Cancers Such as Gastrointesti... | NCT01831609

Studies
Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer

NCT01831609

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jun 15, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Sarcoma

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

Jun 2022

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 31, 2011Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Apr 7, 2013

First Submission Date that Met QC Criteria

Apr 12, 2013

First Posted Date

Apr 15, 2013Estimated

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

Jun 13, 2022

Last Update Posted Date

Jun 15, 2022Actual

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

To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary cultures from metastatic cancer patients. The specimens will be analyzed using DNA/RNA/proteomic approaches.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biomarker analyses to predict treatment response in metastatic cancer	Using patient derived tumor cells, predictive biomarker analyses (DNA, RNA protein levels etc) will be assessed.	3 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
Written informed consent
body fluid derived from cancer, available for drainage and collection

Exclusion Criteria:

patients who do not give informed consent form for research use of biomaterials/biospecimens

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

1. Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeeyun Lee, MD	Contact	822-3410-3459		jyun.lee@samsung.com

Overall Officials

Name	Affiliation	Role
Jeeyun Lee, professor	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided