Predictors of clinical outcomes in Adenoid Cystic Carcinoma of Head and Neck : An Ambispective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival Outcomes - OS(Overall Survival), LRRFS(Loco-Regional Recurrence Free Survival), DFS(Disease Free Survival).
研究概览
简要总结
AIM AND OBJECTIVESAim:To assess the predictors of clinical outcomes in patients of Adenoid Cystic carcinoma of the head and neck.
ObjectivesPrimary Objectives
**a)**To study the demographic, clinical, radiological, and pathological distribution in patients of Head and Neck Adenoid Cystic Carcinoma treated by surgical or non- surgical modalities. (age, sex, socioeconomic status, comorbidities, grade, stage, nodal status, distant metastasis, previous treatment, histological report, margin status, adjuvant therapy etc.).
**b)**To study the impact of these clinicopathological factors on survival outcomes (Overall Survival - OS, Loco Regional Recurrence Free Survival – LRRFS, and Disease- Free Survival – DFS).
Secondary Objectivesa) To determine the Quality of Life (QoL) in AdCC patients.
**b)**To ascertain differences in outcomes of major versus minor salivary gland AdCC and localized disease versus distant metastatic disease.
**c)**To study association of NOTCH1 mutations with AdCC and its impact on survival outcomes (Subject to funding).
Material and MethodsStudy Design– Ambispective Observational Study
Study Duration– One and a half years
Study Setting**1.**Department of Otorhinolaryngology and Head-Neck Surgery, All India Institute of Medical Sciences, New Delhi (AIIMS)
**2.**Department of Head and Neck Oncology,
National Cancer Institute, Jhajjar, Haryana (NCI)
**3.**Head and Neck Lab, Department of Pathology, AIIMS, New Delhi.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Histologically proven Adenoid Cystic Carcinoma. Site.
- •Head and neck region. Subsites.
- •Nose, PNS, Orbit, Ear, Oral cavity, Pharynx, Larynx, Salivary Glands. Stage- I to IV as per AJCC 8th edition. Treated by any of the modalities at AIIMS or NCI JAJJHAR from JAN. 2014 till DEC. 2025.
排除标准
- •Non Adenoid Cystic Histology.
- •Patient not giving consent.
结局指标
主要结局
Survival Outcomes - OS(Overall Survival), LRRFS(Loco-Regional Recurrence Free Survival), DFS(Disease Free Survival).
时间窗: At 3 months
次要结局
- QOL(Quality Of Life)(3 months)
研究者
Dr. Dinesh Kumar Sharma
AIIMS, New Delhi.
