Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis.

Cancer Clinical Trial

Official title:

Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis in the Neck: A Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03837613
• Other study ID #: MohamedGhorabMSc
• Status: Not yet recruiting
• Start date: February 2019
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: Mohamed Ghorab, BDS
• Phone: 01002841441
• Email: ddsmghorab[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Does the tumor thickness value of buccal squamous cell carcinomas, predict cervical nodal metastasis in clinically and radio-graphical neck negative (N0) thus sparing such patients unnecessary surgical procedures and it's associated morbidities? The aim of the study is to evaluate the prognostic value of tumor thickness cut off 4 mm in predicting cervical nodal metastases in a population of Egyptian patients presenting with Buccal Squamous Cell Carcinoma. The hypothesis is that patients with tumor thickness less than 4 mm will present with significantly less cervical nodal metastasis.

Description:

Patients will be recruited from the outpatient clinics of Al Monofia university hospital, Cairo University Hospital and National Cancer Institute. Patients who fits the inclusion criteria and are motivated and consent to enter the study will be included. Patient recruitment will continue until the target sample size is reached.

Patients data will be collected including personal data, medical history, family history, and classification of the tumor according to the TNM classification system. Patients will be assessed preoperatively with a transcutaneous high frequency probe ultrasound to measure the maximal tumor thickness in millimeters using a 10MHz superficial probe and the lymph nodes in the neck region. In addition to clinical examination and palpation of the neck lymph nodes. Patients will then undergo tumor resection surgery with adequate safety margins under GA with nasotracheal intubation. Selective neck dissection will then be performed. The specimens will be submitted for histopathological examination.

Patients will receive standard post operative care based on the recommendation of the oncologist. Adjunct chemo or radiotherapy will be administered when deemed necessary. Wound care and dressings will be administered as needed.

Patients will be categorized into two groups based on the tumor thickness (exposure).

For the primary outcome, the data source will be the measurement of tumor depth based on Berslow method as discussed in the review of literature, obtained from ultrasonography and recorded in millimeters.Tumor width recorded in (mm) will also be obtained from the ultrasonography as it may be a source of confounders. Further, histological grade of the lesion will also be recorded.

Two confounding factors are highlighted and may be sources of bias and attempt to control for them in the statistical analyses will be made.

Appropriate statistical methods will be used after collection of the data and sources of confounders will be controlled for during analyses in subgroup An attempt to control for tumor width and histological grade in subgroup analyses

All data will be entered electronically. Patients' files are to be stored in numerical order and stored in secure and accessible place. All data will be maintained in storage for 1 year after completion of the study. Data monitoring committee is independent from the sponsor and competing interest.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Egyptian patients with BSCC (T all N0) not previously operated or treated with adjunctive therapy. They should present with no clinical signs of neck lymph nodes involvement.

Exclusion Criteria:

• Patients with lesions secondary to another primary site.

• Patients previously removed a primary oral surgery tumor in another site

• Patients with clinical or radiographic evidence of cervical nodal metastases

Related Conditions & MeSH terms

• Cancer
• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Procedure:
• tumor resection and neck dissection
Surgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes.

Locations

Country	Name	City	State
Egypt	Cairo University - Faculty of Oral and Dental Medicine	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Mohamed Ghorab	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Deshpande G, Das S. Tumor Thickness: A predictor of nodal disease in early squamous cell carcinomas of buccal mucosa. Gulf J Oncolog. 2015 May;1(18):37-43. — View Citation

Huang SH, Hwang D, Lockwood G, Goldstein DP, O'Sullivan B. Predictive value of tumor thickness for cervical lymph-node involvement in squamous cell carcinoma of the oral cavity: a meta-analysis of reported studies. Cancer. 2009 Apr 1;115(7):1489-97. doi: 10.1002/cncr.24161. — View Citation

Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical nodal metastasis	Number of patients with positive cervical nodal metastasis	one week after the surgery
Secondary	Tumor thickness	Correlation between the tumor thickness measured preoperatively by ultrasound versus the tumor thickness measured from the histopathological specimen	one week after the surgery