Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430053
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2007-01-30
Brief Title:
Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pathogenesis And Course Of Cutaneous T-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-03
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:
RATIONALE Gathering information about patients with cutaneous T-cell lymphoma over time may help doctors learn more about the disease
PURPOSE This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma
PURPOSE This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Follow the disease course of patients with cutaneous T-cell lymphoma
Provide a patient population for study by proteomic and molecular analysis
Develop a mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials
Secondary
Develop a tissue bank for future disease study using specimens from these patients
Provide community outreach by offering a second opinion regarding treatment of this disease in these patients and in limited cases provide standard-of-care treatment to these patients
Develop an algorithm for screening and evaluating this disease in these patients
OUTLINE Patients undergo disease assessment by physical examination full-body photographic documentation of skin disease biopsy and blood sampling at baseline and then at least annually thereafter Proteomic and molecular methods are used to analyze samples Biopsies may be examined using histologic and immunohistochemical methods Blood may be analyzed by polymerase chain reaction for clonal T-cell gene rearrangements or by flow cytometry
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 5 years
Primary
Follow the disease course of patients with cutaneous T-cell lymphoma
Provide a patient population for study by proteomic and molecular analysis
Develop a mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials
Secondary
Develop a tissue bank for future disease study using specimens from these patients
Provide community outreach by offering a second opinion regarding treatment of this disease in these patients and in limited cases provide standard-of-care treatment to these patients
Develop an algorithm for screening and evaluating this disease in these patients
OUTLINE Patients undergo disease assessment by physical examination full-body photographic documentation of skin disease biopsy and blood sampling at baseline and then at least annually thereafter Proteomic and molecular methods are used to analyze samples Biopsies may be examined using histologic and immunohistochemical methods Blood may be analyzed by polymerase chain reaction for clonal T-cell gene rearrangements or by flow cytometry
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000354510 | None | None | None |
| 04-C-0081 | None | None | None |