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CTRI Number  CTRI/2020/11/028987 [Registered on: 09/11/2020] Trial Registered Prospectively
Last Modified On: 05/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive study 
Study Design  Other 
Public Title of Study   Clinical characteristics of patients with lung mass in a tertiary hospital in a sub-himalayan region 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul kumar 
Designation  Senior Resident  
Affiliation  AIIMS, Rishikesh  
Address  Departement Of Surgical oncology, AIIMS Rishikesh
Sturida Colony, Rishikesh,
Dehradun
UTTARANCHAL
249203
India 
Phone  8800335660  
Fax    
Email  drraulinsa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankaj Kumar Garg 
Designation  Additional Professor 
Affiliation  AIIMS, Rishikesh  
Address  Departement Of surgical ONcology, AIIMS rishikesh
Sturida Colony, Rishikesh,
Dehradun
UTTARANCHAL
249203
India 
Phone  8800335660  
Fax    
Email  dr.pankajgarg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul kumar 
Designation  Senior Resident  
Affiliation  AIIMS, Rishikesh  
Address  Departement of Surgical Oncology, AIIMS Rishikesh
Sturida Colony, Rishikesh,
Dehradun
UTTARANCHAL
249203
India 
Phone  8800335660  
Fax    
Email  drraulinsa@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Rishikesh 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Rishkesh, Dehradun, UK 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Kumar   AIIMS , Rishikesh  Departement of surgical oncology and Departement of Pulmonology
Dehradun
UTTARANCHAL 
8800335660

drraulinsa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethics Committee, AIIMS Rishikesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with radiologically detected single lung mass, or multiple masses in patient not known to have malignancy 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Different histopathological causes of lung masses.  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/11/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide and Lung mass is the most common radiologic presentation of lung (1). An extensive literature search to look for standard evidence based description of lung mass and its management protocols highlighted scarcity af literature - lung mass continues to remain an ill-defined entity. Conventionally, a lung mass is defined as ‘any pleural or pulmonary lesion seen on chest radiograph as an opacity greater than 3 cm’(2). Pulmonary nodule is the term used for any rounded or irregular opacity measuring 3 cm or less 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, inflammatory myofibroblastic tumor and pulmonary liposarcoma. These differentials are frequently discussed in the literature; however, there is paucity of evidence to suggest proportional distribution of these etiologies. Subsequently. a tissue diagnosis is required to confirm the diagnosis and manage the patient accordingly.

Lung cancer is the leading cause of cancer-related mortality worldwide including India. However, mortality rates are higher in india as large number of cases are diagnosed with advanced stage disease, one of the attributable cause of poor treatment outcome.(4) Delay in diagnosis in patients with lung mass is a potential cause of progression of disease and delay in treatment. Delay in diagnosis can occur at various levels, and a number of factors are responsible for it. Primary delay is defined as time duration between the occurrence of symptoms and the first contact with the clinician. In other words, whne a patiet delays seeking medical care in the early stage of disease when symptoms are mild. Common factors that contribute to primary delay are – (a) lack of awareness, (b) poverty, (c)  unavailablilty of health care facilities in the vicinity, and (d) widespread presence of unrqualified medical practitioners. Secondary delay is defined as the period between the patient contact with the clinician and the definitive diagnosis of the disease.(5) Causes of secondary delay usually includes – institution of empirical treatment (usually antituberculsosis treatment) by the clinicians or unqualified practitioners, scarcity of expertise for tissue biopsy, and long waiting time at public hospitals.  

Tuberculosis is endemic to Indian subcontinent and is one of the disease which may masquaerade lung cancer very closely in both clinical and radiological features. In a developing economy like India, every fifth case of lung cancer is initially diagnosed as sputum-negative tuberculosis and treated accordingly (6). Empirical anti-tuberculosis treatment is highly prevalent in India due to high prevalence of  pulmonary tuberculosis and is a major attribute to secondary delay in the diagnosis of lung cancer. Sarcoidosis masquerading as lung malignancy and vice versa is often reported and can, at times, be a diagnostic challenge. These factors delay the diagnosis of lung cancer and results in poor treatment outcomes.

The study is aimed to analyze the possible causes of lung masses in  patients residing in a subhimalayan region and the reasons for delay in definite diagnosis. An attempt will be made to generate score based on clinico-pathological characteristics of lng masses to diagnoses lung cancer. This score can help avoid the delays in the management of lung cancer.

 
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