Head and Neck Surgery/Oncology, Amrita Institute of Medical Sciences - Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.
Medical Oncology, Amrita Institute of Medical Sciences - Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.
F1000Res. 2023 Jul 26;12:889. doi: 10.12688/f1000research.138951.1. eCollection 2023.
Tongue tumors show intra and inter-tumoral heterogenicity with high incidence, relapse and mortality rates necessitating further research. Recurrence/metastasis that occurs after surgical resection of primary cancer is often the reason for poor survival in these patients. Lymph nodes are the most common site of metastasis in tongue tumors. Therefore, premetastatic molecular changes can be best evaluated in lymph nodes which may epitomize the earliest events in the metastasis cascades. The presence of circulating tumor cells(CTCs) in the absence of nodal disease (N0) may represent tumor aggressiveness, suggesting an immune escape which may have high metastatic potential. This trial was developed to investigate the earliest pre-metastatic changes which may regulate tumor dormancy and predict metastasis. A better understanding of organotropism or pre-metastatic changes can help in theragnostic, thereby preventing the outbreak of overt metastasis. A single-institutional prospective observational cohort study. This trial will be conducted at a tertiary care Centre (Amrita Institute of Medical Sciences Kochi). Eligible patients will be enrolled after obtaining informed consent. The dissected lymph nodes will be subjected to histopathological and immunohistochemical analyses for premetastatic niche (PMN) formation. In addition, circulating tumor cells will be evaluated before treatment and 6 months after treatment. The patients will be followed up for a period of two years to correlate the findings with the recurrence-free survival. The pre-metastatic changes, if detected will be a predictive biomarker. It may help to define future drug targets for metastasis chemoprevention . CTCs may define the tumor aggressiveness ,there by prognostication and helps in better disease management. The study has received the following approval: Ethics Committee of Amrita School of Medicine (ECASM-AIMS-2022-048).Trial Registered Prospectively( CTRI/2022/03/041256 ) on 22/03/2022 under Clinical Trial Registry of India.
舌肿瘤具有高发、复发和死亡率高的特点，因此需要进一步研究。原发性癌症手术后的复发/转移常常是这些患者生存不良的原因。淋巴结是舌肿瘤转移的最常见部位。因此，在淋巴结中可以最好地评估转移级联中最早发生的前转移分子变化。在没有淋巴结疾病（N0）的情况下循环肿瘤细胞（CTC）的存在可能代表肿瘤的侵袭性，表明存在免疫逃逸，可能具有很高的转移潜力。本试验旨在研究最早的前转移变化，这些变化可能调节肿瘤休眠并预测转移。更好地了解器官趋向性或前转移变化有助于治疗诊断，从而预防明显转移的爆发。一项单机构前瞻性观察队列研究。该试验将在三级护理中心（Amrita Institute of Medical Sciences Kochi）进行。获得知情同意后，将招募符合条件的患者。将对解剖的淋巴结进行前转移龛（PMN）形成的组织病理学和免疫组织化学分析。此外，将在治疗前和治疗后 6 个月评估循环肿瘤细胞。将对患者进行为期两年的随访，将发现与无复发生存率相关联。如果检测到前转移变化，将其作为预测生物标志物。它可能有助于确定转移化学预防的未来药物靶点。CTC 可以定义肿瘤的侵袭性，从而进行预后并帮助更好地进行疾病管理。该研究已获得以下批准：Amrita 医学院伦理委员会（ECASM-AIMS-2022-048）。于 2022 年 3 月 22 日在印度临床试验注册处进行前瞻性注册（CTRI/2022/03/041256）。
