跳至主要内容
临床试验/CTRI/2020/11/028987
CTRI/2020/11/028987尚未招募不适用

Clinico-pathological characteristics of patients with lung mass with emphasis on lung cancer in a tertiary teaching hospital in a sub-himalayan region: a prospective descriptive study

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Different histopathological causes of lung masses.

研究概览

简要总结

Lung cancer is the leading cause of cancer-relatedmorbidity and mortality worldwide and Lung mass is the most common radiologicpresentation of lung (1). An extensiveliterature search to look for standard evidence based description of lung massand its management protocols highlighted scarcity af literature - lung mass continuesto remain an ill-defined entity. Conventionally, a lung mass is defined as ‘any pleural or pulmonary lesion seen on chest radiographas an opacity greater than 3 cm’(2). Pulmonarynodule is the term used for any rounded or irregular opacity measuring 3 cm orless in diameter surrounded by normal lung parenchyma (3). Differentail diagnosis of a lung mass includes lung neoplasm, tuberculosis,nodular Sarcoidosis, lung abscess, focal organizing pneumonia, inflammatorymyofibroblastic tumor and pulmonary liposarcoma. These differentials arefrequently discussed in the literature; however, there is paucity of evidenceto suggest proportional distribution of these etiologies. Subsequently. atissue diagnosis is required to confirm the diagnosis and manage the patientaccordingly.

Lung cancer is theleading cause of cancer-related mortality worldwide including India. However,mortality rates are higher in india as large number of cases are diagnosed withadvanced stage disease, one of the attributable cause of poor treatment outcome.(4) Delay in diagnosis in patients with lung mass is apotential cause of progression of disease and delay in treatment. Delay indiagnosis can occur at various levels, and a number of factors are responsiblefor it. Primary delay is defined as time duration between the occurrence ofsymptoms and the first contact with the clinician. In other words, whne apatiet delays seeking medical care in the early stage of disease when symptomsare mild. Common factors that contribute to primary delay are – (a) lack ofawareness, (b) poverty, (c)  unavailabliltyof health care facilities in the vicinity, and (d) widespread presence ofunrqualified medical practitioners. Secondary delay is defined as the periodbetween the patient contact with the clinician and the definitive diagnosis ofthe disease.(5) Causes of secondary delay usually includes –institution of empirical treatment (usually antituberculsosis treatment) by theclinicians or unqualified practitioners, scarcity of expertise for tissuebiopsy, and long waiting time at public hospitals.

Tuberculosisis endemic to Indian subcontinent and is one of the disease which maymasquaerade lung cancer very closely in both clinical and radiologicalfeatures. In a developing economy like India, every fifth case of lung cancer isinitially diagnosed as sputum-negative tuberculosis and treated accordingly (6). Empirical anti-tuberculosistreatment is highly prevalent in India due to high prevalence of  pulmonary tuberculosis and is a majorattribute to secondary delay in the diagnosis of lung cancer. Sarcoidosismasquerading as lung malignancy and vice versa is often reported and can, attimes, be a diagnostic challenge. These factors delay the diagnosis of lungcancer and results in poor treatment outcomes.

Thestudy is aimed to analyze the possible causes of lung masses in  patients residing in a subhimalayan regionand the reasons for delay in definite diagnosis. An attempt will be made togenerate score based on clinico-pathological characteristics of lng masses todiagnoses lung cancer. This score can help avoid the delays in the managementof lung cancer.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients with radiologically detected single lung mass, or multiple masses in patient not known to have malignancy.

排除标准

  • Simultaneous presence of a non-pulmonary neoplasm with multiple lung metastasis where biopsy is not contemplated.
  • History of prior malignancy with short remission.
  • Any contraindication for the biopsy Poor performance status (ECOG 3 or more), uncorrectable coagulopathy , Un- cooperative patient, Severe Pulmonary hypertension.

结局指标

主要结局

Different histopathological causes of lung masses.

时间窗: at baseline

次要结局

  • Duration of primary and secondary delay in diagnosis of primary lung mass.(first visit)
  • Clinico- radiological profile of the neoplastic causes of lung mass(2 weeks)
  • 4.Histopathological type, immunohistochemical markers and stage of the patients diagnosed with lung cancer(1 month)

研究者

申办方类型
Government medical college

研究点 (1)

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