Radiation-Induced Cytokine Cascades and Their Correlation... | NCT00178295

Studies
Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury

NCT00178295

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Aug 5, 2015Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Brain Neoplasm

Interventions

Radiation Therapy

Countries

United States

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

Aug 2015

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

Nov 1999

Primary Completion Date

Dec 2013Actual

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

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

Aug 3, 2015

Last Update Posted Date

Aug 5, 2015Estimated

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

Treatment for brain cancer may include radiation therapy. Radiation therapy is the treatment of tumors with X-rays. This study is related to understanding the side effects of radiation treatment for brain tumors.

This study is being conducted by the University of Rochester Cancer Center to compare the extent of side effects of brain cancer treatment with changes in levels of blood proteins called cytokines.

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

44Actual

Name	Type	Description	Arm Group Labels	Other Names
Radiation Therapy	Radiation	standard of care for the cancer being treated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Cytokine blood levels		12 weeks from start of radiation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient who will be treated to the brain or spinal axis for a CNS tum Patients so treated will be stratified according to whether or not the hypo is included in the treatment fields.
Patients receiving external beam radiation to the brain may also be rece chemotherapy or interferon-beta. (Add. #1, 11-9-95)
Patients receiving high dose rate (stereotactic radiosurgery) are eligible.
Patients must sign a study specific informed consent meeting all federal a guidelines.
Patients of any age, including children, are eligible (Add. #3, 11/25/97).

Exclusion Criteria:

Patients who have a malignancy involving the hypothalamic-pituitary ax
Patients who are not treated with irradiation to the brain or spinal axis.

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

Patient who are going to receive radiation therapy as part of the treatment for their brain cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louis S Constine, MD	Universtiy of Rochester, Dept of Radiation Oncology	Study Chair
Ralph Brasacchio, MD	University of Rochester, Department of Radiation Oncology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester, Dept. Radiation Oncology		Rochester	New York	14642	United States

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided