| CTRI Number |
CTRI/2017/11/010599 [Registered on: 23/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
role of CT scan in thyroid cancer |
|
Scientific Title of Study
|
Role Of Computed Tomography In Evaluation Well Differentiated Papillary
Thyroid Cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil DCruz |
| Designation |
Director, TMH |
| Affiliation |
Tata Memorial Hospital |
| Address |
Roon no 1201
12th Floor
HBB, Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
docdcruz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil DCruz |
| Designation |
Director, TMH |
| Affiliation |
Tata Memorial Hospital |
| Address |
Roon no 1201
12th Floor
HBB, Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
docdcruz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil DCruz |
| Designation |
Director, TMH |
| Affiliation |
Tata Memorial Hospital |
| Address |
Roon no 1201
12th Floor
HBB, Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
docdcruz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata MemorialHospital
Dr E Borges Raod
Parel, Mumbai |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Anil DCruz |
Tata Memorial Hospital |
Roon no 1201
12th Floor
HBB
Mumbai
MAHARASHTRA |
022-24177000
docdcruz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Well differentiated papillary carcinoma thyroid, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All thyroid nodule patients getting registered in TMH
2. No prior treatment.
3. Age of the patient 18 years and above
|
|
| ExclusionCriteria |
| Details |
1. Patients who have received treatment outside TMH
2. Age less than 18 years
3. Allergy to contrast
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity, specificity, PPW, NPW and accuracy of ultrasound alone, computed tomography alone and both together in diagnosing regional metastasis in the thyroid cancers. |
after the completion of the acrrual |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
28/12/2015 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
On completion of study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the utility of ultrasound and computed tomography in detecting central and lateral compartment nodal metastasis in well differentiated thyroid cancer.
Evaluation of the
histopathologically proven thyroid cancers for the regional metastasis using
ultrasound and computed tomography. To perform level wise radiopathologic
correlation following surgery. To determine the sensitivity, specificity and
accuracy of both the imaging modality individually and together in diagnosing
thyroid malignancy and lateral and central compartment metastasis. |