None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate whether the presence of two antibodies, eIF4E and p53, in samples of tissue from the edge of surgically removed tumours in the head and neck may correspond with cancer progression and recurrence. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with mucosal head and neck squamous cell carcinoma with negative surgical margins on histopathology at the Royal Darwin Hospital or the Christian Medical College, Vellore (India). Study details: All participants enrolled in this study will have tests carried out on tissue samples which were taken at the time of surgery, and which have already been shown to be tumour-free. These tests will assess for the presence of the two antibodies eIF4E and p53. Participants will then be followed-up for minimum of 12 months - end of study period by review of medical records, to see if any correlation exists between presence of the antibodies and cancer recurrence. It is hoped that the findings of this study may provide information on whether these antibodies may be used as a marker for prognosis in head and neck cancer patients at the time of surgery.
Interventions
As part of the routine management patients diagnosed with mucosal head and neck squamous cell carcinoma undergo wide local excision. The surgical margins are identified and labeled by the surgeon before the biopsy specimens are sent for routine histopathological analysis. The specimens that are reported to have all the margins free of tumour are enrolled in the study for Immunohistochemical analysis. The tumour free mucosal margins undergo further immunostaining with p53 and eIF4E. This study on
As part of the routine management patients diagnosed with mucosal head and neck squamous cell carcinoma undergo wide local excision. The surgical margins are identified and labeled by the surgeon before the biopsy specimens are sent for routine histopathological analysis. The specimens that are reported to have all the margins free of tumour are enrolled in the study for Immunohistochemical analysis. The tumour free mucosal margins undergo further immunostaining with p53 and eIF4E. This study only involves the immunohistochemistry analysis using p53 and eIF4E. The follow up period for each participant is minimum of 12 months for disease recurrence /progression
Sponsors
Rama Jayaraj
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients diagnosed with mucosal head and neck squamous cell carcinoma with negative surgical margins on histopathology at the Royal Darwin Hospital and Christian Medical College Vellore
Exclusion criteria
Patients diagnosed with any other histological type of mucosal head and neck cancers, and whose primary modality of therapy was surgery. *Patients whose surgical margins showed dysplasia, carcinoma – in – situ, tumour and was less than 5mm distant from invasive tumour on histopathological examination *Patients with metastatic disease except a single regional lymph node with no extracapsular spread *Patients with multiple foci of peri-neural invasion Patients with lymphovascular invasion *Patients with previous radiotherapy and chemotherapy *Patients in whom the margins cannot be defined or with an unknown primary *Patients under 18 years of age *Patients who are pregnant
Outcome results
None listed