Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002695
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
CLINICAL EFFICACY OF MOLECULAR ANALYSIS OF SURGICAL MARGINS AND REGIONAL LYMPH NODES IN MANAGEMENT OF HEAD AND NECK SQUAMOUS CELL CARCINOMA
Status:
COMPLETED
Status Verified Date:
2023-06
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 such as analysis of tumor tissue and lymph nodes that have been surgically removed may improve the treatment of patients with cancers of the head and neck
PURPOSE Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically removed from patients with cancers of the head and neck can predict recurrence of the cancer
PURPOSE Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically removed from patients with cancers of the head and neck can predict recurrence of the cancer
Detailed Description:
OBJECTIVES
Determine whether molecular detection of p53 mutation in cancerous cells of histologically negative tumor margins can predict local recurrence in patients with squamous cell carcinoma of the upper aerodigestive tract
Determine the incidence of p53 mutation in this population and its correlation with clinical parameters
Determine whether molecular detection of cancerous cells in lymph nodes from stage N0-1 neck dissections can predict survival and the risks of regional recurrence and distant metastases in these patients
OUTLINE This is a multicenter study
Patients undergo standard curative resection and neck node dissection if appropriate Specimens are collected from tumor tissue necrosis-free if possible each wound quadrant any neck disease with clinically negative nodes and any neck disease with a single positive node for histologic and molecular analysis Tissue and cells are examined for p53 mutation and DNA microsatellite repeat alterations Patients undergo adjuvant radiotherapy andor chemotherapy as appropriate for clinical staging and histopathology at the discretion of the participating clinician
Patients do not receive results of genetic testing and the results do not affect treatment
Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total 530 patients will be accrued for this study within 35 years
Determine whether molecular detection of p53 mutation in cancerous cells of histologically negative tumor margins can predict local recurrence in patients with squamous cell carcinoma of the upper aerodigestive tract
Determine the incidence of p53 mutation in this population and its correlation with clinical parameters
Determine whether molecular detection of cancerous cells in lymph nodes from stage N0-1 neck dissections can predict survival and the risks of regional recurrence and distant metastases in these patients
OUTLINE This is a multicenter study
Patients undergo standard curative resection and neck node dissection if appropriate Specimens are collected from tumor tissue necrosis-free if possible each wound quadrant any neck disease with clinically negative nodes and any neck disease with a single positive node for histologic and molecular analysis Tissue and cells are examined for p53 mutation and DNA microsatellite repeat alterations Patients undergo adjuvant radiotherapy andor chemotherapy as appropriate for clinical staging and histopathology at the discretion of the participating clinician
Patients do not receive results of genetic testing and the results do not affect treatment
Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total 530 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 |
|---|---|---|---|
| E-4393 | None | None | None |