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| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 17, 2002 |
| Last Updated Date | August 24, 2009 |
| Start Date ICMJE | April 2002 |
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE |
To determine the hepatic progression free survival of pts with melanoma metastatic to liver in pts treated with percutaneous hepatic perfusion of melphalan with subsequent venous hemofiltraion (PCP) versus best alternative therapy. |
| Change History | Complete list of historical versions of study NCT00033969 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE |
To determine the response rate to PHP in patients with cutaneous and ocular melanoma metastatic to liver. |
| Descriptive Information | |
| Brief Title ICMJE | Study of Proteins Associated With Complex Regional Pain Syndrome |
| Official Title ICMJE | Complex Regional Pain Syndrome Proteomics Study |
| Brief Summary | This study will try to learn more about complex regional pain syndrome, or CRPS (previously known as reflex sympathetic dystrophy, spreading neuralgia, and sympathalgia), by examining the release of small proteins in the blood of patients with this condition. Patients with CRPS usually have three types of symptoms:
The cause of CRPS is unknown, and there are no definitive diagnostic tests for the condition. Because early treatment improves the prognosis of CRPS, a test that enables early diagnosis would be important for optimal medical management. The findings of this study may contribute to the development of such a test and possibly new drug treatments. Normal healthy volunteers and patients of any age with complex regional pain syndrome who are in otherwise good general health may be eligible for this study. Participants will have a medical history, physical examination and collection of a blood sample. They will fill out several questionnaires, providing information on their health, personality, mood, pain levels, and symptoms. Participation in the study requires one outpatient clinic visit. ... |
| Detailed Description | The etiology of Complex Regional Pain Syndrome (CRPS) is unknown but a patient typically presents with a triad of clinical findings: sensory abnormalities, perfusion abnormalities and alterations in motor function. Since some of these findings are seen in the other disease states, the diagnosis is often not clear. A response to a sympathetic ganglion block (stellate or lumbar) is also suggestive of the disorder. However, there is no definitive diagnostic test for CRPS. Experience has shown that early aggressive treatment improves the prognosis. Therefore, tests that facilitate the early diagnosis would have important clinical implications. Advances in laboratory techniques allow analysis of clinical samples to identify protein or patterns of protein changes associated with a disease state. Patients suffering with CRPS who are currently seen in a pain clinic will be asked to participate in this study. The subjects will complete a brief symptom survey, be examined by a co-investigator to document sensory, temperature and trophic changes, and have a blood sample collected. Blood samples from age-matched controls will be collected from non-CRPS patients. Fifty patient samples collected from each group will be analyzed and used to teach the diagnostic software and an additional 20 samples (10 controls, 10 CRPS patients) will be used to validate diagnostic accuracy. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 120 |
| Completion Date | |
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE |
Male or female volunteers referred by their physician with the diagnosis of CRPS Age restrictions: none Good general health Willing to have blood drawn Willing to have behavioral measures Willing to provide a directed medical history There is expected to be a greater number of females than males being recruited to this study since there is a much higher occurrence of CRPS in women. Additionally, it is expected to be equal across all ethnic groups. However, we do not anticipate requiring any special recruiting strategies for specific gender or ethnic groups. EXCLUSION CRITERIA Contradiction to blood screening Advanced disease other than the CRPS (cardiovascular, liver, kidney disease-ASA III or above excluding CRPS) that may cause a theoretical inclusion of samples resulting in confounding results. No exclusions will be made based on race, gender, or religion. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00033969 |
| Responsible Party | |
| Study ID Numbers ICMJE | 020169, 02-D-0169 |
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | December 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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