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Hypothesis
Study Design
A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.
Hypothesis
Study Design
A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neck dissection of at least the ipsilateral sub-level 1B | Procedure | neck dissection of at least the ipsilateral sub-level 1B |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland. | The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland. | Post Surgical Time point |
| Measure | Description | Time Frame |
|---|---|---|
| The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread. | Pathological detection of carcinoma within each of the dissected nodes reported as node groups. | Post surgical time point |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Robbins, M.D. | SIU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12117328 | Background | Robbins KT, Clayman G, Levine PA, Medina J, Sessions R, Shaha A, Som P, Wolf GT; American Head and Neck Society; American Academy of Otolaryngology--Head and Neck Surgery. Neck dissection classification update: revisions proposed by the American Head and Neck Society and the American Academy of Otolaryngology-Head and Neck Surgery. Arch Otolaryngol Head Neck Surg. 2002 Jul;128(7):751-8. doi: 10.1001/archotol.128.7.751. No abstract available. |
| Label | URL |
|---|---|
| sponsoring institution website | View source |
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Treatment planning was performed for all patients in the multidisciplinary head and neck oncology forum before recruitment into the trial.
Dates of recruitment: 06/11/2008 through 09/17/2009 Number of patients recruited: 23 Number of patient completing trial: 20
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery | A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery | A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland. | The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland. | Posted | Mean | Standard Deviation | nodes | Post Surgical Time point |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgery | A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Simmons Cancer Institute at Southern Illinois University School of Medicine | 217-545-1946 | krobinson@siumed.edu |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C025484 | iso-sulfan blue |
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| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| submandibular gland excision | Number | participants |
|
| sublevel IB dissection | Number | participants |
|
| surgical bed inspection | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread. | Pathological detection of carcinoma within each of the dissected nodes reported as node groups. | Posted | Mean | Standard Deviation | carcinoma positive nodes | Post surgical time point |
|
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| 0 |
| 20 |
| 0 |
| 20 |
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| Title | Measurements |
|---|---|
|
| Retroglandular nodal positivity right neck |
|
| Preglandular nodal positivity left neck |
|
| Prevascular nodal positivity left neck |
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| Retrovascular nodal positivity left neck |
|
| Retroglandular nodal positivity left neck |
|