National Cancer Institute Thai Cancer Anemia Survey | NCT01030159

Studies
National Cancer Institute Thai Cancer Anemia Survey

NCT01030159

Sponsor

Janssen-Cilag Ltd.,Thailand

Status

Completed

Last Update Posted

Apr 9, 2014Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Anemia
Cancer

Interventions

Adult Cancer Patients

Countries

Thailand

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

ID	Type	Description	Link
TCAS-NCI-ONCO-2006

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Dec 10, 2009

First Submission Date that Met QC Criteria

Dec 10, 2009

First Posted Date

Dec 11, 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 8, 2014

Last Update Posted Date

Apr 9, 2014Estimated

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 purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.

Detailed Description

Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemaglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered

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

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
001			Other: Adult Cancer Patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adult Cancer Patients	Other	Tracking anemia management in Adult Cancer Patients	001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients that have anemia during cancer therapy		6 months

Secondary Outcomes

Measure	Description	Time Frame
Characteristics of patients example treatment duration, type of chemotherapy used, grade of anemia		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with cancer

Exclusion Criteria:

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

Anemic patients with cancer receiving chemotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janssen-Cilag Ltd Clinical Trial	Janssen-Cilag Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Bangkok			Thailand

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia
D009369	Neoplasms

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided