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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178295
First Posted: September 15, 2005
Last Update Posted: August 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louis Constine, University of Rochester
  Purpose

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.


Condition Intervention
Brain Neoplasm Radiation: Radiation Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury

Resource links provided by NLM:


Further study details as provided by Louis Constine, University of Rochester:

Primary Outcome Measures:
  • Change from baseline in Cytokine blood levels [ Time Frame: 12 weeks from start of radiation ]

Biospecimen Retention:   Samples Without DNA
Blood plasma

Enrollment: 44
Study Start Date: November 1999
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Radiation Therapy
    standard of care for the cancer being treated
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who are going to receive radiation therapy as part of the treatment for their brain cancer
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178295


Locations
United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Study Chair: Louis S Constine, MD Universtiy of Rochester, Dept of Radiation Oncology
Study Chair: Ralph Brasacchio, MD University of Rochester, Department of Radiation Oncology
  More Information

Responsible Party: Louis Constine, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00178295     History of Changes
Other Study ID Numbers: URCC 11095
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: August 5, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Brain Neoplasms
Trauma, Nervous System
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries