Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00871533
Status:
TERMINATED
Last Update Posted:
2017-08-04
First Post:
2009-03-26
Brief Title:
Pilot Study of IFN α2b for Melanoma Patients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pilot Analysis of the Effects of IFN α2b Upon the Molecular Profile of Regional Lymph Nodes in Melanoma Patients With and Without Tumor-Involved Sentinel Lymph Nodes
Status:
TERMINATED
Status Verified Date:
2017-08
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:
The presence of malignant cells in lymph nodes is a critical parameter in the staging of melanoma cancer patients Assessment of lymph nodes is currently done by histopathology alone The long-term survival of melanoma cancer patients who have Stage IB disease no known lymph node involvement with a tumor greater than 2 cm is lower than patients who are Stage IA no known lymph node involvement with a tumor less than 2 cm Likewise the survival rates of patients who are judged to be Stage II based on histologically positive level-one lymph nodes is often no better than that of higher stage patients who have level-two lymph node involvement These observations suggest that micrometastases are often present in lymph nodes that are not detectable by histological assessment
The collection of Sentinel Lymph Nodes SLN and non SLN material outlined in this proposal will permit both targeted and exploratory studies without compromising the patients diagnosis on specimens that represent central engines of the immune response and whose function in the context of tumor progression is largely unknown
With the advent of an array of new methodologies that utilize minimum material for both molecular and cellular assessments acquiring up to 20 and in general the investigators anticipate the use of 5 on average of SLN andor non SLN tissue for research purposes may prove to be critical to understanding the impact of nodal tumor involvement on patient outcome and survival
The collection of Sentinel Lymph Nodes SLN and non SLN material outlined in this proposal will permit both targeted and exploratory studies without compromising the patients diagnosis on specimens that represent central engines of the immune response and whose function in the context of tumor progression is largely unknown
With the advent of an array of new methodologies that utilize minimum material for both molecular and cellular assessments acquiring up to 20 and in general the investigators anticipate the use of 5 on average of SLN andor non SLN tissue for research purposes may prove to be critical to understanding the impact of nodal tumor involvement on patient outcome and survival
Detailed Description:
None
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