| CTRI Number |
CTRI/2021/02/031057 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
20/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Use of immunohistochemical markers in Non Small Cell Lung Carcinoma with histopathological correlation |
|
Scientific Title of Study
|
TTF-1 and P40 immunohistochemical markers as a useful panel in diagnosis of Non Small Cell Lung Carcinoma (NSCLC) with histopathological correlation- A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College & Hospital, Bareilly |
| Address |
1108, Gali no.3, Arya nagar, Kosi Kalan, Mathura, U.P, Pincode- 281403 Department of Pathology, Rohilkhand Medical College, Bareilly, U.P. Mathura UTTAR PRADESH 281403 India |
| Phone |
9639830830 |
| Fax |
|
| Email |
m.k.60.ma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Anjana Arya |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College & Hospital, Bareilly |
| Address |
Department of Pathology, Rohilkhand Medical College and Hospital, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9412125824 |
| Fax |
|
| Email |
anjanaarya.singh15@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mayank Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College & Hospital, Bareilly |
| Address |
1108, Gali no. 3, Arya nagar, Kosi Kalan, Mathura Department of Pathology, Rohilkhand Medical College, Bareilly, U.P. Mathura UTTAR PRADESH 281403 India |
| Phone |
9639830830 |
| Fax |
|
| Email |
m.k.60.ma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College & Hospital, Bareilly |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College Hospital |
| Address |
4, Pilibhit byepass road, opposite suresh sharma nagar, Bareilly |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mayank Agrawal |
Rohilkhand Medical College and Hospital |
Department of Pathology Bareilly UTTAR PRADESH |
9639830830
m.k.60.ma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All histopathologically diagnosed cases of lung carcinomas of any age group or sex received in our Pathology Department during study period. |
|
| ExclusionCriteria |
| Details |
1)Inadequate lung biopsies.
2)Non-carcinomatous lesions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TTF-1 and P40 immunohistochemical markers as a useful panel in diagnosis of Non Small Cell Lung Carcinoma. |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Role of TTF-1 and P40 immunohistochemical markers in differentiating NSCLC.
|
Nil |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2021 |
| Date of Study Completion (India) |
09/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published Article in JMSH
Topic- Diagnostic Utility of TTF-1 and P40 Immunohistochemical Markers for Subtyping of non small cell lung carcinoma |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [m.k.60.ma@gmail.com].
- For how long will this data be available start date provided 28-07-2022 and end date provided 28-12-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Lungs are air-filled spongy organ located on either side of the chest. The inhaled air conducts through the large air passages that lead from the trachea to the lungs through called bronchi. The right and left bronchi after entering in to the lungs, they are further divided in to segmental bronchi. The segmental bronchi then further divided in to bronchioles, finally becoming microscopic. The bronchioles then further divided in to terminal bronchioles then in to respiratory bronchioles eventually end in clusters of microscopic air sacs called alveoli where exchange of gases takes place. In lungs, there are several types of lesions broadly classified as Inflammatory and Non-inflammatory, Polyp and Tumors. Tumors are classified as Benign includes Hamartomas, Bronchial adenomas, Chondromas, Fibromas, Lipomas and Malignant is histologically classified in to two main groups i.e. Small cell lung carcinoma (SCLC) constitutes 15% of all lung cancer and Non- Small cell lung carcinoma (NSCLC) constitutes 85% of all lung cancer while NSCLC is subclassified in to Adenocarcinoma, Squamous cell carcinoma, Large cell carcinoma in which adenocarcinoma is most predominant type.1 Lung cancer is the second most common and major cause of death worldwide.2 Its generally a disease of elderly individuals, occurring most often between ages 55 and 84 years.1 In India, lung cancer constitutes 6.9% of all new cancer cases and 9.3% of all cancer related deaths in both sexes.3 Incidence of lung cancer in male is 1 in 68 and in female is 1 in 201.4 The most common cause of lung cancer is Tobacco Smoking which accounts for 80% and other causes includes air pollution, industrial hazards like asbestos, arsenic, chromium, nickel, vinyl chloride which accounts for 20%.2 Early detection and treatment may result in decreasing incidence of the mortality and morbidity. |