| CTRI Number |
CTRI/2019/04/018753 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
04/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CORRELATION OF BRONCHOSCOPIC AND RADIOLOGICAL FINDINGS IN SUSPECTED LUNG CANCER AND ITS OUTCOME |
|
Scientific Title of Study
|
CORRELATION OF BRONCHOSCOPIC AND RADIOLOGICAL FINDINGS IN SUSPECTED LUNG CANCER AND ITS OUTCOME- A CROSS SECTIONAL STUDY IN A TERTIARY CARE HOSPITAL |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjun AS |
| Designation |
Junior Resident |
| Affiliation |
Ramaiah Medical College |
| Address |
Ramaiah Medical College
M S R Nagar MSRIT Post
Mathikere Bangalore 560054 Ramaiah Medical College
M S R Nagar MSRIT Post
Mathikere Bangalore 560054 Bangalore KARNATAKA 560054 India |
| Phone |
|
| Fax |
|
| Email |
arjunlalu.2306@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gayathri Devi H J |
| Designation |
Professor and HoD |
| Affiliation |
MS Ramaiah Medical College |
| Address |
MS Ramaiah Medical College
M S R Nagar MSRIT Post
Mathikere Bangalore 560054 MS Ramaiah Medical College
M S R Nagar MSRIT Post
Mathikere Bangalore 560054 Bangalore KARNATAKA 560054 India |
| Phone |
|
| Fax |
|
| Email |
gayathrijoshy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arjun AS |
| Designation |
Junior Resident |
| Affiliation |
Ramaiah Medical College |
| Address |
Ramaiah Medical College
M S R Nagar MSRIT Post
Mathikere Bangalore 560054 Ramaiah Medical College
M S R Nagar MSRIT Post
Mathikere Bangalore 560054 Bangalore KARNATAKA 560054 India |
| Phone |
|
| Fax |
|
| Email |
arjunlalu.2306@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Respiratory Medicine, Room No 6, ground floor,
MS Ramaiah Memorial Hospital
MSR nagar, MSR IT post, Mathikere, Bangalore -560054 |
| Department of Respiratory Medicine. Room No 28, Ground floor
MS Ramaiah Medical College Hospital
MSR nagar, MSR IT post, Mathikere, Bangalore-560054
(no monetory support) |
|
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Primary Sponsor
|
| Name |
Ramiah Medical College |
| Address |
MSR nagar, MSRIT post, Bnagalore 560054 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arjun AS |
MS Ramaiah Medical College Hospital |
Department of Respiratory Medicine, Room No 28, ground floor, MSR nagar, MSRIT post, Bangalore 560054 Bangalore KARNATAKA |
7795077550
arjunlalu.2306@gmail.com |
| Dr Arjun AS |
MS Ramaiah Memorial hospital |
Department of Respiratory Medicine, Room No 6, ground floor, MSR nagar MSR IT post, Mathikere, Bangalore 560054 Bangalore KARNATAKA |
7795077550
arjunlalu.2306@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. clinical features suggestive of malignancy such as hemoptysis, unexplained weight loss, loss of appetite, unexplained persistent cough, hoarsnes of voice
2. Radiological features suggestive of lung malignancy
3.un explained and recurrent pleural effusion |
|
| ExclusionCriteria |
| Details |
1. coagulopathy,
2. platelets < 50,000/dl
3. pulmonary hypertension
4. Recent myocardial infarction or unstable angina
5. inability to cooperate during the procedure. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Characterize Bronchoscopic findings in patients with Suspected Lung cancer and Correlate wit CT thorax and thereby asses positive predictive value |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse the histopathological findings on biopsy |
1 year 6 months |
|
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Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
30/04/2019 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
data collection not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Need for the study: Bronchoscopy and computed tomography of the thorax are the most common investigations utilized to screen and diagnose lung cancer. their individual utility in diagnosing lung cancer has been demonstrated by numerous studies. Studies correlating the two modalities in Indian setup are few. Hence this study will be done to analyze the bronchoscopy findings and the radiological correlation of suspected cases of lung malignancy at our tertiary care hospital, thus asses its positive predictive value. objectives: 1. To characterize bronchoscopic findings in patients with suspected lung cancer and correlate with CT thorax 2. To analyse the histopathological findings on biopsy Methodology: inclusion and exclusion criteria as mentioned All patients with suspected lung carcinoma and for whom bronchoscopy is indicated, fiber optic bronchoscopy and biopsy will be done, their bronchoscopic findings will be noted. The patient will be followed up and the Histopathological examination and IHC reports will be noted. Bronchoscopic evaluation will be done by Respiratory medicine team, CT image findings will be reported by radiologists and histopathological examination will be done by pathologists at our tertiary care centre. Statistical analysis: descriptive statistics of confirming lung carcinoma will be analyzed and summarized in terms of percentage and its 95% confidence interval will be estimated. The diagnostic yield of bronchoscopic biopsy will be done by validating with positive predictive value.
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