CTRI/2024/02/063074尚未招募不适用
step serial sectioning of lymph node in oral squamous cell carcinoma for micrometastasis and extranodal extension:A cross sectional study
Mahima jaiswal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To classify oral squamous cell carcinomas based on pathological tumor(pT) and nodal
研究概览
简要总结
- The study will be conducted in the Department of Pathology, Rohilkhand Medical College and Hospital, Bareilly after taking approval from Institutional Ethics Committee.
- The recieved specimen will be subjected to gross and microscopic examination as per standard protocol.
- The largest lymph node will be identified and measured.
- Lymph node <5mm will be submitted as whole and those with size >5mm will be bisected into two halves and submitted in one cassette.
- Paraffin embedded tissues (4-5 micron) will be cut and stained by Hematoxylin and Eosin stain.
- After staining slide will be subjected to microscopic examination and decision for step serial sectioning will be taken as under:-
- In the microscopy cases with largest lymph node identified as positive but ENE negative will be subjected to step serial sectioning to identify ENE.
- Those lymph node which are identified as node negative on routine H&E staining ie NO will be further taken up for step serial sectioning to look for micrometastasis and ENE involvement by two independent pathologist.
- Serial microsections each measuring 4-5 micro meter will be retained every 100 micrometer till the tissue is completely exhausted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All histopathologically diagnosed cases of oral squamous cell carcinoma undergoing radical neck dissection and showing: Node negative(NO) on pN staging pN stage N1-N3 with ENE negative status.
排除标准
- •â€¢ Cases showing both nodal positivity and ENE positivity on H&E staining.
- •â€¢ Cases of oral squamous cell carcinoma who have undergone pre-operative chemotherapy and radiotherapy.
- •â€¢ Cases with recurrence of disease.
- •â€¢ Cases with any concurrent malignancy.
结局指标
主要结局
To classify oral squamous cell carcinomas based on pathological tumor(pT) and nodal
时间窗: 4 weeks
stage(pN)
时间窗: 4 weeks
To determine the percentage increased nodal positivity in the node negative (NO) cases of radical neck dissection of oral squamous cell carcinoma on applying step serial
时间窗: 4 weeks
sectioning.
时间窗: 4 weeks
To calculate the percentage of increased ENE positive status in cases of ENE negative and nodal positive squamous cell carcinoma with use of step serial sectioning.
时间窗: 4 weeks
次要结局
- To classify oral squamous cell carcinomas based on pathological tumor(pT) & nodal stage(pN)
研究者
Mahima jaiswal
Rohilkhand Medical college and hospital
研究点 (1)
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