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临床试验/CTRI/2025/02/081124
CTRI/2025/02/081124尚未招募不适用

Predictors of clinical outcomes in Adenoid Cystic Carcinoma of Head and Neck : An Ambispective Analysis

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月3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
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

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Dinesh Kumar Sharma

AIIMS, New Delhi.

研究点 (1)

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