| CTRI Number |
CTRI/2024/06/069527 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of benign and malignant body cavity effusion |
|
Scientific Title of Study
|
Comparison of benign and malignant body cavity effusion by automated hematological analyser and flow cytometry |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archi Agrawal |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of pathology, Room no 52 pathology block, pathology block
Maulana Azad medical college
New Delhi
110002
India
Central
DELHI
110002
India |
| Phone |
8955738714 |
| Fax |
|
| Email |
archiagra25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr khuraijam bembem |
| Designation |
Assistant professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Room no 54,Department of Pathology, Pathology block,
Maulana Azad medical college
New Delhi
110002
India
DELHI
110002
India |
| Phone |
9811570454 |
| Fax |
|
| Email |
bemkhuraijam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archi agrawal |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad medical college |
| Address |
Pathology block, department of pathology
Maulana Azad medical college
New Delhi
110002
India
DELHI
110002
India |
| Phone |
8955738714 |
| Fax |
|
| Email |
archiagra25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college
2 Bahadur shah Zafar marg
New Delhi
110002
India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
Maulana Azad medical college, 2- Bahadur shah Zafar marg, New Delhi 110002 |
| Type of Sponsor |
Government 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 |
| Dr Archi Agrawal |
Maulana Azad medical college |
Room no 54 Department of pathology
Pathology block
Maulana Azad medical college
2 Bahadur shah Zafar marg
New Delhi
110002
India
Central
DELHI |
8955738714
archiagra25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital (Lok Nayak, G.I.P.M.E.R., Guru Nanak Eye Centre, New Delhi 110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C76||Malignant neoplasm of other and ill-defined sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All cases of body cavity effusion in individuals aged 18 years or more |
|
| ExclusionCriteria |
| Details |
Cases with less than 2ml or degenerated fluid. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Total and differential leukocyte counts in body cavity effusion
2. Proportion of cases showing expression of Ep-CAM, CD14 and CD45 in suspicious cases or cases with malignancy |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of cytological features
(presence of reactive mesothelial cells, atypical mitosis, cytological atypia, presence of
three-dimensional clusters) with clinical parameters (weight loss, biochemical
parameters, radiological details, stage of the disease) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2024 |
| 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 Applicable |
| 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
|
COMPARISON OF BENIGN AND MALIGNANT BODY CAVITY EFFUSION BY AUTOMATED HEMATOLOGICAL ANALYSER AND FLOW CYTOMETRY Malignancies often impact the serosal cavities (pleural, peritoneal, and pericardial), usually through metastatic spread from sources like the lungs, breasts, female genital tract, or gastrointestinal tract. Flow cytometry is not commonly used for characterizing epithelial and mesothelial cells in diagnostic settings. However, it offers the advantage of being a quick quantitative method applicable to live cells in fresh specimens, preventing fixation artifacts. This technique accurately identifies cytoplasmic, nuclear, and surface antigens. Additionally, multicolour flow cytometry enables the simultaneous assessment of multiple antigens. |