Patients with cervical cancer who are scheduled for radical hysterectomy and underwent a pre- operative MRI and PET- CT that have demonstrated a tumor ≥2- 4cm cm and the absence of nodal metastasis on imaging will be offered to give consent and participate.~After anesthesia and immediately prior to surgery, the surgeon will perform a large loop biopsy of depth of 1.5 and a diameter of 1.0 cm from the cervical tumor. Hemostasis can be achieved by the usual measures or by packing. Surgery will follow immediately as planned.~In patient who in the course of the preoperative evaluation underwent large loop biopsy histologic analysis of this biopsy will be performed similarly. If the large loop specimen is appropriate (>1.5X1cm) and allows assessment of all the histologic risk factors, no repeat large loop biopsy will be performed.~In patient that the that the previous large loop biopsy is not be appropriate for complete histologic analysis and the surgeon asses that a repeat biopsy is technically feasible, a large loop biopsy will be performed prior to the radical hysterectomy as described above.~All histological evaluation will be carried out as usual in hospital in which the surgery was performed.~In addition, centralized pathological analysis will be performed in Hillel Yaffe Medical center The histopathological features to be included in the report: type of procedure, tumor site, histologic type of tumor, histologic grade, depth of stromal invasion, pattern of invasion (*), horizontal extent of stromal invasion, the distance of tumor from surgical margins, lymphovascular invasion, LVSI will be assess and reported after D2-40and CD31 immunostatins.~Descriptive demographic, clinical and pathology data will be noted. The histopathological features noted above and size of tumor as measured on MRI will be recorded.~The rate of the presence of both LVSI and invasion greater 10 mm in the pre- operative loop biopsy will be assessed.~At least 52 patients will be included in the study~Sample size calculation:~The minimal sample size required to demonstrate the non-inferiority of Method B (findings in LEEP) is 52. Assuming that the proportions of patients with the presence of both LVSI and tumor invasion greater than 10 mm, method A (standard post- surgery evaluation) and method B are 25%, with α=0.05, β=0.2, and non-inferiority margin of 15%.
A pre- operative evaluation for the presence of intermediate risk factors prior to surgery may allow for better patient counselling, modify the course of surgery or select patients to undergo primary chemo- radiation.~The purpose of this study is to validate that the presence of histological risk factors in a pre-operative large loop biopsy highly correlates with post-operative histological evaluation and the subsequent indication for post-operative chemo-radiation