Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042926
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2002-08-05
Brief Title:
Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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:
RATIONALE Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment
PURPOSE Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth
PURPOSE Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth
Detailed Description:
OBJECTIVES
Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity
Determine the extent and pattern of disease spread in the nodal bed in these patients
Obtain data on the use of immunohistochemistry to assess nodes in these patients
Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity
Determine the extent and pattern of disease spread in the nodal bed in these patients
Obtain data on the use of immunohistochemistry to assess nodes in these patients
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 |
|---|---|---|---|
| CDR0000069485 | REGISTRY | NCI Physician Data Query | None |