Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049010
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2002-11-12
Brief Title:
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma
Status:
COMPLETED
Status Verified Date:
2016-06
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 that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer
PURPOSE This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma
PURPOSE This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma
Detailed Description:
OBJECTIVES
Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma
Correlate melastatin expression prospectively with event-free survival of these patients
OUTLINE This is a multicenter study
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1 Patients do not receive the results of these tests nor do the results influence individual therapy
Patients are followed every 4 months for 35 years
PROJECTED ACCRUAL A total of 300 patients will be accrued for this study within 35 years
Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma
Correlate melastatin expression prospectively with event-free survival of these patients
OUTLINE This is a multicenter study
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1 Patients do not receive the results of these tests nor do the results influence individual therapy
Patients are followed every 4 months for 35 years
PROJECTED ACCRUAL A total of 300 patients will be accrued for this study within 35 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 |
|---|---|---|---|
| CDR0000257230 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-500105 | None | None | None |