| CTRI Number |
CTRI/2025/12/098345 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
levels of Cell free DNA in malignant thyroid nodules |
|
Scientific Title of Study
|
Cell free DNA as markers of malignancy in thyroid nodules |
| 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 Smita Sonoli |
| Designation |
Professor and Head of Department Of Biochemistry |
| Affiliation |
KAHER Jawaharlal Nehru Medical College |
| Address |
Department of Biochemistry, Jawaharlal Nehru Medical college, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09901662601 |
| Fax |
|
| Email |
naragundsmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Sonoli |
| Designation |
Professor and Head of Department Of Biochemistry |
| Affiliation |
KAHER Jawaharlal Nehru Medical College |
| Address |
Department of Biochemistry, Jawaharlal Nehru Medical college, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09901662601 |
| Fax |
|
| Email |
naragundsmita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Sonoli |
| Designation |
Professor and Head of Department Of Biochemistry |
| Affiliation |
KAHER Jawaharlal Nehru Medical College |
| Address |
Department of Biochemistry, Jawaharlal Nehru Medical college, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09901662601 |
| Fax |
|
| Email |
naragundsmita@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Smita Sonoli |
| Address |
Department of Biochemistry Jawaharlal Nehru Medical College Nehru nagar Belagavi |
| 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 Smita Sonoli |
Dr. Prabhakar Kore Hospital and medical research center |
Department of Biochemistry
Hi- Tech Laboratory
second floor
Belgaum
KARNATAKA |
9901662601
naragundsmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive patients attending the endocrinology OPD |
|
| ExclusionCriteria |
| Details |
Hyperthyroidism with multi nodular disease on ultrasonography.
Anaplastic cancer and medullary thyroid cancer.
Patients with past/current history of any known malignancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To detect thyroid malignancies at an early stage, improving treatment outcomes and patient survival rates |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
13/12/2025 |
| 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)
Modification(s)
|
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
|
Introduction Thyroid malignancy is the most common endocrine malignancy which usually presents as a solitary thyroid nodule. Studies have suggested that 5 percent to 15 percent of all thyroid nodules evaluated are malignant. We propose to differentiate malignant from benign thyroid nodules by quantification of plasma cell free DNA. |