| CTRI Number |
CTRI/2024/05/068176 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Expression of various cancer markers in thyroid cancer |
|
Scientific Title of Study
|
Immunohistochemical expression of CK19 and CD56 in thyroid neoplasms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanu Priya |
| Designation |
PG student |
| Affiliation |
BPS Govt Medical College for women Khanpur Kalan Sonipat |
| Address |
Department of Pathology, BPS GMC (W), Khanpur kalan, Sonipat, Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8569856332 |
| Fax |
|
| Email |
tanupriyasheoran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Gathwal |
| Designation |
Professor |
| Affiliation |
BPS Govt Medical College for women Khanpur Kalan Sonipat |
| Address |
Department of Pathology, BPS GMC (W), Khanpur kalan, Sonipat, Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8569856332 |
| Fax |
|
| Email |
drmonikabgathwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanu Priya |
| Designation |
PG student |
| Affiliation |
BPS Govt Medical College for women Khanpur Kalan Sonipat |
| Address |
Department of Pathology, BPS GMC (W), Khanpur kalan, Sonipat, Haryana
HARYANA
131305
India |
| Phone |
8569856332 |
| Fax |
|
| Email |
tanupriyasheoran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat phool singh government medical college for women |
|
|
Primary Sponsor
|
| Name |
Tanu Priya |
| Address |
Department of Pathology, BPS GMC (W), Khanpur kalan, Sonipat, Haryana, India, 131305. |
| 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 Tanu Priya |
Dept of Pathology |
Room no 5, BPS GMC, Khanpur kalan, Sonipat, Haryana
Sonipat
HARYANA |
08569856332
tanupriyasheoran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All proven cases of thyroid neoplasm |
|
| ExclusionCriteria |
| Details |
non neoplastic lesions of thyroid
blocks could not be retrieved
cases who had undergone chemotherapy and radiotherapy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CD56 and CK19 |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
30/06/2024 |
| 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
|
Title of my study is immunohistochemical expression of CK19 and CD56 in thyroid neoplasms whose objectives are to classify thyroid neoplasms on the basis of histomorphological features, to estimate the expression of IHC marker CK19 in thyroid neoplasms, to estimate the expression of IHC marker CD56 in thyroid neoplasms, to correlate the expression of CK19 and CD56 in thyroid neoplasms. Sample size is 53. All proven cases of thyroid neoplasms are included. |