Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076830
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2006-07-12
Brief Title:
Evaluation and Treatment of Patients With Connective Tissue Disease
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigations of Bone-Related Connective Tissue Disorders
Status:
COMPLETED
Status Verified Date:
2024-04-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study offers evaluation and treatment of patients with a suspected connective tissue disorder The protocol is not designed to test new treatments rather patients receive standard care The study is designed to 1 allow NICHDs staff to learn more about connective tissue disorders 2 train physicians in the evaluation and treatment of these disorders and 3 establish a pool of patients who may be eligible for other NICHD protocols for connective tissue disorders Participants in this protocol will not be required to join another study the decision will be voluntary
Patients of all ages with a suspected connective tissue disorder and their unaffected family members may be eligible for this study
Participants undergo diagnostic procedures that may include a medical history physical examination X-ray studies eye examinations and blood drawing as well as other specialized tests when needed Additional tests may include
Blood test for DNA genetic analysis
Skin biopsy Removal of a small piece of tissue for microscopic examination The area of skin selected for the biopsy is numbed and a small circle of skin usually from the upper arm is removed with a surgical cookie cutter-like instrument
Magnetic resonance imaging MRI This test uses a strong magnetic field and radio waves to show structural and chemical changes in tissues The patient lies on a table that slides into a narrow cylinder containing a magnetic field Ear plugs are worn to muffle loud knocking and thumping sounds that occur with electrical switching of the magnetic fields
Computed tomography CT scans This test allows the doctor to view the organs inside the body in small sections The patient lies in a doughnut-like machine Scanning can be done from different angles allowing a three dimensional picture of the part of the body being studied It may be done with or without injection of a contrast material
Referral to appropriate sub-specialists when potential complications are found
Patients of all ages with a suspected connective tissue disorder and their unaffected family members may be eligible for this study
Participants undergo diagnostic procedures that may include a medical history physical examination X-ray studies eye examinations and blood drawing as well as other specialized tests when needed Additional tests may include
Blood test for DNA genetic analysis
Skin biopsy Removal of a small piece of tissue for microscopic examination The area of skin selected for the biopsy is numbed and a small circle of skin usually from the upper arm is removed with a surgical cookie cutter-like instrument
Magnetic resonance imaging MRI This test uses a strong magnetic field and radio waves to show structural and chemical changes in tissues The patient lies on a table that slides into a narrow cylinder containing a magnetic field Ear plugs are worn to muffle loud knocking and thumping sounds that occur with electrical switching of the magnetic fields
Computed tomography CT scans This test allows the doctor to view the organs inside the body in small sections The patient lies in a doughnut-like machine Scanning can be done from different angles allowing a three dimensional picture of the part of the body being studied It may be done with or without injection of a contrast material
Referral to appropriate sub-specialists when potential complications are found
Detailed Description:
This protocol seeks to formalize the application of accepted diagnostic and therapeutic measures in the study of individuals with known or suspected bone-related connective tissue disorders including Osteogenesis Imperfecta and melorheostosis It is our intent to attract a broad array of such individuals for the purposes indicated above This protocol will also serve as a basis for permitting collaborations with other investigators regarding rare illustrative or poorly defined human diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CH-0077 | None | None | None |