| CTRI Number |
CTRI/2024/02/063117 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of cytological and histological diagnosis from bone lesion |
|
Scientific Title of Study
|
Correlation of cytological and histo pathological findings in bone lesions :A cross sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tavleen Bedi |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly |
| Address |
Room no. 1162, Department of Pathology, Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9897194789 |
| Fax |
|
| Email |
dr.tavleenbedi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibhuti Goyal |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly |
| Address |
Department of Pathology Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8979499220 |
| Fax |
|
| Email |
goyal.vibhuti@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tavleen Bedi |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly |
| Address |
Department of Pathology,Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9897194789 |
| Fax |
|
| Email |
dr.tavleenbedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly |
|
|
Primary Sponsor
|
| Name |
Dr Tavleen Bedi |
| Address |
AC girls hostel,Department of Pathology,Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Tavleen Bedi |
Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly |
Room no 1162 , Department of Pathology, Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH |
9897194789
dr.tavleenbedi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RMCH BAREILLY UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C419||Malignant neoplasm of bone and articular cartilage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ALL CASES OF BONE LESIONS WHO WILL UNDERGO BOTH HISTOPATHOLOGY AND CYTOPATHOLOGY |
|
| ExclusionCriteria |
| Details |
BIOPSIES REPORTED AS UNSATISFACTORY FOR EVALUATION
CYTOLOGICAL SAMPLES ONLY HAVING BLOODY ASPIRATE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To classify the bone lesions on the basis of cyto-histomorphological features as per
WHO classification (2020).
To categorize the bone lesions on the basis of age, gender and site. To correlate cytological findings with histopathological findings. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To classify the bone lesions on the basis of cyto-histomorphological features as per
WHO classification (2020).
To categorize the bone lesions on the basis of age, gender & site.
To correlate cytological findings with histopathological findings. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
29/02/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in Department of Pathology in collaboration with Department of Orthopaedics, Rohilkhand Medical College and Hospital, Bareilly after taking approval from Institutional Ethics Committee and with consent from patient will include all cytological and biopsy specimens of bone lesions received in department in one year duration The informed consent to be taken from the patient as per standard protocol.
The patient’s demographic data including gender, age, comorbid conditions and clinical history such as pain, swelling and relevant radiological investigation record will be maintained
The patient will be explained the details of the procedure, and written consent will be documented. A thorough clinical examination will be conducted on the patient and details about the lesion or lump (including site, size, consistency, mobility, and tenderness) will be noted. The procedure (FNA) will be performed under strict aseptic precautions, with prepacked swabs soaked in 70% alcohol. A sterile needle of 20-21 gauge attached to 20 cc disposable syringe mounted in a syringe holder will be positioned above the superficial lesion and advanced gently to puncture the skin. Using two fingers of the other hand to keep the lump fixed, the needle will be advanced into the lesion When sure that the needle tip is inside the target tissue, the plunger will be pulled to apply negative pressure. Multiple passes will be made without exiting the tissue and the needle moved back and forth in different directions to collect sufficient material. With the needle still in the target tissue, the negative pressure will be released. The needle will then be withdrawn from the lesion. Subsequently, the needle will be detached, and air will be drawn into the syringe. After reattachment of the needle to the syringe, the material will be blown onto several clean glass slides, and smeared using a spreader. The gross appearance of the aspirate will be recorded. The slides will be air-dried and stained with Leishman-Giemsa |