Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004153
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
1999-12-10
Brief Title:
Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma
Status:
COMPLETED
Status Verified Date:
2013-09
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 Diagnostic procedures may improve the ability to detect the presence or recurrence of disease
PURPOSE Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma
PURPOSE Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma
Detailed Description:
OBJECTIVES
Determine the feasibility of performing reverse transcriptase-polymerase chain reaction RT-PCR for five different tumor antigen genes using lymph node samples or peripheral blood from patients with melanoma
Determine the ability of PCR-positive lymph nodes or peripheral blood to predict relapse of disease in these patients
Determine the correlation of positive PCR results from peripheral blood with disease stage
OUTLINE Lymph node biopsies or peripheral blood are obtained from patients These specimens are examined by nested reverse transcriptase-polymerase chain reaction RT-PCR and analyzed for various tumor antigens
Patients may choose to be told the results of this testing but the results do not influence or change the planned therapy Brief counseling is required to discuss the results and their potential implications
Patients are followed for at least 2 years
PROJECTED ACCRUAL A total of 30 patients for the lymph node portion and 80 patients 20 per stage of disease for the peripheral blood portion will be accrued for this study within 3 years
Determine the feasibility of performing reverse transcriptase-polymerase chain reaction RT-PCR for five different tumor antigen genes using lymph node samples or peripheral blood from patients with melanoma
Determine the ability of PCR-positive lymph nodes or peripheral blood to predict relapse of disease in these patients
Determine the correlation of positive PCR results from peripheral blood with disease stage
OUTLINE Lymph node biopsies or peripheral blood are obtained from patients These specimens are examined by nested reverse transcriptase-polymerase chain reaction RT-PCR and analyzed for various tumor antigens
Patients may choose to be told the results of this testing but the results do not influence or change the planned therapy Brief counseling is required to discuss the results and their potential implications
Patients are followed for at least 2 years
PROJECTED ACCRUAL A total of 30 patients for the lymph node portion and 80 patients 20 per stage of disease for the peripheral blood portion will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NCI-G99-1620 | None | None | None |
| UCCRC-9308 | None | None | None |
| UCCRC-CTRC-9767 | None | None | None |