Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection.

NCT03237195 | Completed

• 1 other identifier: 2016-0288
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Most patients with cancer of the head and neck are offered surgical resection of the primary tumor. In order to determine how the tumor will eventually behave, along with the resection of the primary tumor, lymph nodes present in the neck are also dissected. Different institutes have different protocol on handling of the specimen that is received by the pathology labs after dissection of the neck. The investigators intend to analyze the protocol that they use to evaluate the neck dissection specimen.

Conditions

Metastasis

Outcome Measures

Primary Outcomes (1)

• Number of additional lymph nodes obtained with additional sampling of soft tissue

  Number of additional lymph nodes obtained with additional sampling of soft tissue

  3 years

Interventions

additional soft tissue in neck dissections OTHER

Evaluation of submission of additional soft tissue in neck dissections for head and neck squamous cell carcinomas

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent neck dissection for squamous cell carcinomas of head and neck origin.

You may qualify if:

• Neck dissection (unilateral and/or bilateral)
• Primary squamous cell carcinoma of head and neck

You may not qualify if:

• \. Any neck dissection performed outside UMMC and case received as a consult.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (5)

• Gillies EM, Luna MA. Histologic evaluation of neck dissection specimens. Otolaryngol Clin North Am. 1998 Oct;31(5):759-71. doi: 10.1016/s0030-6665(05)70085-2.

  PMID: 9735105 RESULT

• Jose J, Coatesworth AP, MacLennan K. Cervical metastases in upper aerodigestive tract squamous cell carcinoma: histopathologic analysis and reporting. Head Neck. 2003 Mar;25(3):194-7. doi: 10.1002/hed.10194.

  PMID: 12599286 RESULT

• Seethala RR. Current state of neck dissection in the United States. Head Neck Pathol. 2009 Sep;3(3):238-45. doi: 10.1007/s12105-009-0129-y. Epub 2009 Aug 7.

  PMID: 20596978 RESULT

• Muirhead D, Aoun P, Powell M, Juncker F, Mollerup J. Pathology economic model tool: a novel approach to workflow and budget cost analysis in an anatomic pathology laboratory. Arch Pathol Lab Med. 2010 Aug;134(8):1164-9. doi: 10.5858/2000-0401-OA.1.

  PMID: 20670137 RESULT

• van den Brekel MW, Stel HV, van der Valk P, van der Waal I, Meyer CJ, Snow GB. Micrometastases from squamous cell carcinoma in neck dissection specimens. Eur Arch Otorhinolaryngol. 1992;249(6):349-53. doi: 10.1007/BF00179388.

  PMID: 1384570 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Neck Dissection

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lymph Node Excision; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Varsha Manucha

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 2, 2017
• Study Start: January 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: February 20, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)