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

NCT ID: NCT03837613

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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.

Conditions

Cancer; Squamous Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 (TT<4mm)

Patients with a preoperative tumor thickness less than 4 mm. Intervention: tumor resection and neck dissection

tumor resection and neck dissection

Intervention Type: PROCEDURE

Surgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes.

Group 2 (TT >= 4mm)

Patients with a preoperative tumor thickness equal to or more than 4 mm Intervention: tumor resection and neck dissection

tumor resection and neck dissection

Intervention Type: PROCEDURE

Surgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Mohamed Ghorab

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ghorab

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohamed Ghorab, BSD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University - Faculty of Oral and Dental Medicine

Cairo, , Egypt

Countries

Egypt

Central Contacts

Mohamed Ghorab, BDS

Role: CONTACT

ddsmghorab@gmail.com

01002841441

Facility Contacts

Mohamed Ghorab, BDS

Role: primary

ddsmghorab@gmail.com

01002841441

References

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.

Reference Type: BACKGROUND

PMID: 19197973 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19026588 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26003104 (View on PubMed)

Other Identifiers

MohamedGhorabMSc

Identifier Type: -

Identifier Source: org_study_id