Clinical Trial Details (PDF Generation Date :- Tue, 08 Jan 2019 13:37:20 GMT) CTRI Number Last Modified On 23/11/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/12/002192 [Registered on: 02/12/2011] - Trial Registered Retrospectively No Observational Prospective Observational Study Other To find the percentage of different types Lung Carcinomas in valley region of Himachal Pradesh To study the pattern of Lung Carcinoma in valley region of Himachal Pradesh Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL NIL Details of Principal Investigator Dr Rekha Bansal Phone 09459933703 Assistant Professor, Department of Pulmonary Medicine Dr. R.P. Government Medical College, at Tanda Assistant Professor, Department of Pulmonary Medicine, Dr. R.P. Government Medical College, at Tanda drdotrekha@gmail.com Details Contact Person (Scientific Query) Phone 09418071364 AssociateProfessor, Department of Pharmacology Dr. R.P. Government Medical College, at Tanda AssociateProfessor, Department of Pharmacology, Dr. R.P. Government Medical College, at Tanda drdotsharma@gmail.com Details Contact Person (Public Query) AssociateProfessor, Department of Pharmacology Dr. R.P. Government Medical College, at Tanda AssociateProfessor, Department of Pharmacology, Dr. R.P. Government Medical College, at Tanda page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Phone 09418071364 drdotsharma@gmail.com Source of Monetary or Material Support > Dr. R.P. Government Medical College, at Tanda (HP) Type of Sponsor None List of Countries of Principal Investigator Primary Sponsor Details Dr RP Government Medical College at Tanda Dr. R.P. Government Medical College, at Tanda (HP) Government medical college of Site Site Phone/Fax/ Department of Pulmonary Medicine Department of Pulmonary Medicine, Dr. R.P. Government Medical College, at Tanda (HP) 09418071364 01892-267115 drdotsharma@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee of Dr. R.P. Government Medical College, at Tanda (HP) Status Health Type Patients Approved 16/03/2011 Yes Date No Date Specified Condition Patients with Lung Carcinoma Type Details Age From Age To Gender Details Details 1.00 Day(s) 99.00 Year(s) Both Inclusion Criteria All Patients with Lung Carcinoma will be included None Exclusion Criteria page 2 / 5
Primary Outcome Outcome Timepoints Histopathological Pattern of Lung Carcinoma At completion of one Year and 2.5 years Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Histopathological Pattern of Lung Carcinoma Total Sample Size=200 Sample Size from =200 N/A 16/03/2011 No Date Specified Years=2 Months=6 Days=0 Open to Recruitment At completion of 1 year and 2.5 years Study details will be published after completion of one year and completion of study The study will be conducted over a period of 2.5 years in Dr. RP Govt. Med. College, at Tanda after getting permission from IEC. Patients of all age groups and either sex with lung carcinoma will be included in the study. Based on previous records of the department it can be assumed that this duration will generate a sample size of around 200 patients. The study will be conducted in two stages, Stage of screening and stage of final diagnosis. Stage of screening: All the patients, presenting in the OPD of Department of Pulmonary Medicine with complaints and/ or history suggestive of lung carcinoma will be admitted and subjected to A. Detailed Clinical Examination B. X-Ray Chest: If malignancy is suspected then X-ray Chest would be taken to look for any lesion suggestive of malignancy. The X-Ray will be studied by two radiologists (One from Investigators and one Independent observer) C. CT Scan: If malignancy is suspected on clinical examination but X-Ray chest is page 3 / 5
found inconclusive then patient will be subjected to chest CT scan. This also will be studied by two radiologists (One from Investigators and one Independent observer) After screening detailed history of patient will be taken and routine hematological and biochemical investigations will be done as per attached Performa. Counseling of patient and his family and relatives will be done to make them understand the implications, treatment and prognosis of the disease and written informed consent of the patient will be taken. Stage of final diagnosis: In this stage the patient will be subjected to one or more of the following investigations 1. Bronchoscopy with collection of sample 2. Pleural biopsy 3. Lymph node biopsy 4. Fine Needle Aspiration of lung mass (CT guided or blind) or lymph node 5. Pleural fluid aspiration 6. Sputum collection The samples collected from above procedures will be subjected to following page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Laboratory Investigations to establish the diagnosis and find the type of lung carcinoma. a) Histopathological examination of i) Bronchial biopsy ii) Pleural biopsy iii) Lymph node biopsy b) Cytology of i) Bronchial washings & brushings ii) Trans bronchial needle aspiration (TBNA) iii) Fine Needle Aspiration of lung mass (CT guided or blind) or lymph node iv) pleural fluid v) Sputum The data will be analyzed to find the percentage of different types of lung carcinomas as per following WHO classification (WHO 1981). page 5 / 5