Development of Predictive Biomarkers and Novel Approached... | NCT01051492

Studies
Development of Predictive Biomarkers and Novel Approached to Therapy in Breast Cancer

NCT01051492

Sponsor

National University Hospital, Singapore

Status

Unknown status

Last Update Posted

Jan 14, 2014Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Singapore

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

Jan 2014

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 2010

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Jan 15, 2010

First Submission Date that Met QC Criteria

Jan 15, 2010

First Posted Date

Jan 18, 2010Estimated

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

Jan 13, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Description Module

Brief Summary

Breast cancer is a common malignancy world-wide, and is the commonest female malignancy in Singapore, with rising trends in incidence over the last 2 decades. While there have been improvements in treatment, mortality from breast cancer remains significant. Development of biomarkers to predict treatment response and toxicity to anti-cancer agents can rationalize the choice of therapy for the individual patients to optimize treatment outcome and to reduce unnecessary toxicities. Development of novel therapies or novel approaches to therapy is also critical to improve the treatment armamentarium in breast cancer. These research strategies will have an significant impact on breast cancer treatment both in Singapore as well as globally.

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

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This program will recruit mainly cancer patients, predominantly breast cancer patients. The exact inclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.

Exclusion Criteria:

The exact exclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.

Accepts Healthy Volunteers

Yes

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

Any individual who has been diagnosed with breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Soo Chin Lee, MBBS, MRCP	Contact	65 6772 4629		soo_chin_lee@nuhs.edu.sg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital Singapore	Recruiting	Singapore			Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19088019	Background	Tan SH, Lee SC, Goh BC, Wong J. Pharmacogenetics in breast cancer therapy. Clin Cancer Res. 2008 Dec 15;14(24):8027-41. doi: 10.1158/1078-0432.CCR-08-0993.
16361630	Background	Goetz MP, Rae JM, Suman VJ, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL, Flockhart DA, Desta Z, Perez EA, Ingle JN. Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J Clin Oncol. 2005 Dec 20;23(36):9312-8. doi: 10.1200/JCO.2005.03.3266.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases