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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 17, 2000 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | May 2000 | ||||||||
| Estimated Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Determine if addition of TNFerade to pre-op chemoradiotherapy increases the number of pathologic complete responses compared to pre-op chemoradiotherapy alone assessed following complete surgical resection of primary or locally recurrent rectal ca. | ||||||||
| Change History | Complete list of historical versions of study NCT00005664 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
To determine the disease free and overall survival of patients with advance rectal cancer treated with pre-operative chemoradiotherapy with or without TNFerade followed by complete surgical resection and post-operative adjuvant chemotherapy. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Patients With Endocrine-Related Conditions | ||||||||
| Official Title ICMJE | Evaluation of Patients With Endocrine-Related Conditions | ||||||||
| Brief Summary | This study will evaluate patients with a variety of endocrine disorders in order to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) to train physicians in endocrinology. Patients of all ages with endocrine-related conditions may be eligible for evaluation under this protocol. Those enrolled may be required to provide blood, saliva, urine or stool samples, and to undergo ultrasound examination of the thyroid gland, ovaries or testes, adrenal glands or other parts of the body. Laboratory or X-ray studies may be done for diagnostic or treatment purposes. In some cases, patients will receive medical or surgical treatment for their disorder. Patients and family members of patients with a hereditary disorder may be asked to provide a blood sample for genetic analysis. |
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| Detailed Description | This protocol is designed to allow inpatient and outpatient evaluation of patients with a variety of endocrine disorders for purposes of research and physician education in our accredited endocrinology training programs, and to allow for small pilot studies in normal volunteers. The research-directed evaluations may include blood, saliva, urine or stool samples, and/or ultrasound examinations. In some patients with endocrine disorders, laboratory or radiological studies will be performed to confirm the diagnosis or to aid in the management of the patient, as would be done in current clinical practice. In some cases, the patient will receive medical or surgical treatment for their disorder. The purpose of these evaluations or treatments will be to support our clinical training or research missions. |
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| 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 | Recruiting | ||||||||
| Enrollment ICMJE | 1600 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Patients of all ages with endocrine-related conditions will be eligible for this protocol. EXCLUSION CRITERIA: Unstable patients and patients with severe organ failure that may affect/limit the endocrine work-up and exhaust Clinical Center and/or NICHD resources will be excluded if appropriate. Decisions will be made on a case by case basis by the principal and associate investigators. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00005664 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 000127, 00-CH-0127 | ||||||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | March 2009 | ||||||||
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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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