Registry for Analysis of Quality of Life, Normal Organ To... | NCT02644993

Studies
Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy

NCT02644993

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Oct 14, 2016Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Pediatric Cancer Patients

Interventions

Proton therapy

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 2016

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

Nov 2015

Primary Completion Date

Nov 2025Estimated

Completion Date

Not provided

First Submitted Date

Dec 28, 2015

First Submission Date that Met QC Criteria

Dec 31, 2015

First Posted Date

Jan 1, 2016Estimated

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 12, 2016

Last Update Posted Date

Oct 14, 2016Estimated

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 study aim of this study is to evaluate the effect of proton therapy on quality of life and long-term normal tissue toxicities of the pediatric cancer patients. Based on these results, the predictive model of long-term normal tissue toxicities, survival, and quality of life could be recognized. Risk-adapted treatment strategy based on the predictive model in pediatric cancer patients could be established.

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

400Estimated

Label	Type	Description	Intervention Names
Proton beam therapy	Experimental		Radiation: Proton therapy

Name	Type	Description	Arm Group Labels	Other Names
Proton therapy	Radiation		Proton beam therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life Questionnaire		within 2 weeks before proton beam therapy

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life Questionnaire baseline		within 1 week before proton beam therapy completion
Quality of Life Questionnaire		3-6 months after proton beam therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

less than 18 years of age
patient who is planned to receive proton therapy at Samsung Medical Center
Informed consent

Exclusion Criteria:

Refuse to participate this cohort study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Do Hoon Lim, MD, PhD	Contact	82-2-3410-2612		dh8.lim@samsung.net
Jeong Il Yu, MD	Contact			ro.yuji651@gmail.com

Overall Officials

Name	Affiliation	Role
Do Hoon Lim, MD, PhD	Proton therapy center, Samsung Medical Center	Principal Investigator

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D061766	Proton Therapy

Ancestor Terms

ID	Term
D063193	Heavy Ion Radiotherapy
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided