| CTRI Number |
CTRI/2024/05/068134 [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 b cell leukemia/ lymphoma 2 and Kiel67 in thyroid
neoplasms. |
|
Scientific Title of Study
|
Immunohistochemical expression of bcl2 and Ki-67 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 |
Vijyendra puri goswami |
| Designation |
Pg resident |
| Affiliation |
Bhagat phool singh government medical college for women |
| Address |
Department of pathology, bhagat phools singh govt medical college(w), khanpur kalan , sonipat
Near vijay chowk , changorabhata , raipur (c.g.)
Sonipat
HARYANA
131305
India |
| Phone |
7999740747 |
| Fax |
|
| Email |
vijyendra0408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swaran kaur saluja |
| Designation |
Hod and professor |
| Affiliation |
Bhagat phool singh government medical college for women |
| Address |
Dept of pathology , bpsgmc (w), khanpur kalan , sonipat
Sonipat
HARYANA
131305
India |
| Phone |
7999740747 |
| Fax |
|
| Email |
swarnkaur123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijyendra puri goswami |
| Designation |
Pg resident |
| Affiliation |
Bhagat phool singh government medical college for women |
| Address |
F block , bpsgmc (w), khanpur kalan , sonipat
Near vijay chowk , changorabhata , raipur (c.g.)
Sonipat
HARYANA
131305
India |
| Phone |
7999740747 |
| Fax |
|
| Email |
vijyendra0408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat phool singh government medical college for women, khanpur kalan , sonipat |
|
|
Primary Sponsor
|
| Name |
Bhagat phool singh government medical college for women khanpur kalan sonipat |
| Address |
Dept of pathology, bhagat phool singh government medical college for women , khanpur kalan , sonipat , 131305, india |
| 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 |
| Vijyendra puri goswami |
Bhagat phool singh government medical college for women |
Dept of pathology, bhagat phool singh government medical college for women Khanpur kalan , sonipat
Sonipat
HARYANA |
7999740747
vijyendra0408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee bhagat phool singh government medical college for women |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All proven cases of thyroid neoplasms |
|
| ExclusionCriteria |
| Details |
1.Non neoplastic lesions of thyroid gland.
2.Blocks which could not be retrieved.
3.Cases who had undergone radiotherapy and chemotherapy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the immunohistochemical expression of bcl2 and Ki-67 in thyroid |
48 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To analyse the various histo-morphological features of thyroid neoplasms.
2.To determine the expression of immunohistochemical marker bcl2 in thyroid neoplasms.
3.To determine the expression of immunohistochemical marker Ki-67 in thyroid neoplasms. |
48 weeks |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
12/06/2024 |
| 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 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
|
The thyroid gland arises as a median outgrowth from the floor of pharynx near the base of tongue. Thyroid neoplasms include a wide range of lesions with various histopathologic characteristics.The benign neoplasms are mainly adenomas which are typically discrete, solitary masses, derived from follicular epithelium, and hence they are also known as follicular adenomas (FA). Malignant thyroid neoplasms are mainly carcinomas, accounting for about 1.5% of all cancers. Although these neoplasms are diagnosed using precise criteria, it is challenging to distinguish between some neoplasms, such as follicular adenoma and follicular carcinoma. Hence, additional diagnostic tests that can help with this differentiation would be very beneficial in the clinical scenario. Thyroid cancer is the most common endocrine cancer today. Its incidence has increased all over the world in the last three decades. An accurate diagnosis of thyroid neoplasm is therefore crucial as it has a major impact on the treatment modality as well as the patient’s prognosis. This study is being done to determine expression of bcl2 and Ki-67 in thyroid neoplasms and to correlate these with histopathological finding. |