RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01885299 |
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Recruitment Status :
Recruiting
First Posted : June 24, 2013
Last Update Posted : July 21, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Neoplasms Arteriovenous Malformation of Central Nervous System Trigeminal Neuralgia | Radiation: SRS/SBRT |
The Registry is designed to help SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) users to understand utilization of and key treatment outcomes for these treatment approaches. Some of the objectives include:
Allow participants to record information about usage of SRS/SBRT in everyday practice, including patient characteristics and disease information, treatment plans and outcomes Provide participants with ready access to data for publication of their own experience and as a tool for establishing collaborations with other participating sites Facilitate quality improvement efforts for individual treatment providers Understand the effectiveness of different treatment plans for different types of lesions, diseases and treatments
The Registry tracks select outcomes for each condition treated by SRS/SBRT (for example, PSA for prostate cancer); the Registry also provides individual participants the ability to add additional outcomes for each and any condition of specific interest to their institutions.
The Registry is hosted by Vision Tree, Inc who is an independent vendor of electronic registries; they are responsible for HIPAA compliance, including all security mechanisms.
Patients will be enrolled prospectively. Some retrospective patient data is likely to be included in order to capture both short and longer term outcomes data.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 50000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 20 Years |
| Official Title: | Multi-Institution Registry of SRS/SBRT Procedures |
| Study Start Date : | March 2012 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients being treated by SRS/SBRT
Patients with a condition being considered for treatment by SRS/SBRT
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Radiation: SRS/SBRT
Intervention varies by condition being treated. |
- Overall survival [ Time Frame: Up to 5 years ]Survival from time of treatment to death
- Local and distant recurrence [ Time Frame: One to Five years ]Calculated from time of treatment to recurrence
- Treatment toxicity [ Time Frame: Immediate -5 years ]Complications of treatment. These complications are organ specific depending on which organ is being treated. For example, if the prostate is being treated,there may be rectal and urinary complications. If the brain is being treated, there may be headaches or nausea. The Radiation Therapy Oncology Group (RTOG) scale used for defining and measuring complications of radiotherapy is incorporated into the Registry database.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Diagnosis of benign or malignant tumors or other conditions deemed treatable by stereotactic radiosurgery or stereotactic body radiotherapy
- Willingness to sign an Informed Consent Document or verbally agree to participation
Exclusion Criteria:
- There are no specific exclusion criteria, but patients who are unwilling to sign the ICD or who decline participation will not be included
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): NCT01885299
| Contact: Jan Jenkins, RN | jjenkins@therss.org | ||
| Contact: Joanne Davis, PHD | jdavis@therss.org |
Show 25 study locations
| Study Director: | Anand Mahadevan, MD | The Radiosurgery Society |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Radiosurgery Society |
| ClinicalTrials.gov Identifier: | NCT01885299 |
| Obsolete Identifiers: | NCT01563549 |
| Other Study ID Numbers: |
RSSearch Patient Registry |
| First Posted: | June 24, 2013 Key Record Dates |
| Last Update Posted: | July 21, 2021 |
| Last Verified: | July 2021 |
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Radiosurgery CyberKnife Benign tumors Malignant tumors Cranial tumors Extracranial tumors |
Lung Liver Pancreas Prostate Stereotactic radiosurgery Stereotactic body radiotherapy |
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Trigeminal Neuralgia Neuralgia Arteriovenous Malformations Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Congenital Abnormalities Vascular Malformations |
Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Trigeminal Nerve Diseases Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases |