An ambispective study on outcomes in anal cancers receiving chemo-radiation with exploratory biomarker analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Expression of various molecular markers (p16, p53, PD-L1 and CAIX) in patients with anal cancer and correlate this with response to chemo-radiotherapy and treatment response rates at 6 months.
研究概览
简要总结
The incidence of Anal cancers in India is increasing and there has been a sharp rise in the incidence in the past decade. The established treatment for anal canal cancer is concurrent chemoradiotherapy.
Anal canal cancer is found to be associated with various biomarkers. The presence of these biomarkers can give invaluable insight into their association with anal cancer its and prognosis and outcomes. In the long run, this will benefit the scientific community in predicting anal cancer outcomes and developing new targeted therapy that may change the efficacy of treatment.
In this study, we study the anal cancer in detail and various markers associated with it. We will use already collected tissue biopsy from patients showing signs and symptoms relevant to anal cancer and once carcinoma is established, we will use that biopsied sample to check for molecular markers. The presence of markers will be documented and will be correlated with response to chemo-radiotherapy and survival and any association between presence of these molecular markers, patient and disease characteristics and disease outcomes. Treatment will be according to the standard protocol and no additional tests will be required. This study will be conducted at Mahamana Pandit Madan Mohan Malviya Cancer Centre & HBCH, Tata Memorial centre, Varanasi.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Histological diagnosis of Squamous cell carcinoma of anal canal.
- •Patients being treated with curative intent with concurrent chemo- radiotherapy (CTRT) -Age of patient 18 years or older -ECOG status 0 – 2 -Patient consenting for participation in study (Written informed consent for prospective patients, Telephonic informed consent for retrospective patients).
排除标准
- •Unwilling to participate in the study.
- •Presence of distant metastases.
- •Medical condition precluding curative intent treatment for the patient.
- •History of previous treatment for current condition.
结局指标
主要结局
Expression of various molecular markers (p16, p53, PD-L1 and CAIX) in patients with anal cancer and correlate this with response to chemo-radiotherapy and treatment response rates at 6 months.
时间窗: 1.5 years
次要结局
- Baseline expression of these moecular markers and their association with acute treatment toxicities based on RTOG toxicity criteria and disease status at 6 months. Also the prevalence of molecular markers in the study population. and association between presence of these molecular markers, patient and disease characteristics and disease outcomes.
研究者
Dr Satyajit Pradhan
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital