| CTRI Number |
CTRI/2024/05/067432 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Predicting papillary thyroid cancer recurrence: a machine learning approach |
|
Scientific Title of Study
|
An exploratory study to predict recurrence of papillary thyroid carcinoma using clinico‑pathological factors with different machine learning algorithms in a tertiary care hospital |
| 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 Reena Patil |
| Designation |
Post Graduate |
| Affiliation |
Manipal college of Health Professions |
| Address |
Department of Health information management ,Manipal College of
Health Professions, Manipal Academy of Higher Education
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9008027890 |
| Fax |
|
| Email |
reena.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sabu K M |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Dept. Health Information Management, Manipal College of Health Professions (MCHP), MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845421534 |
| Fax |
|
| Email |
sabu.km@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumeet Suresh Malapure |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Hospital |
| Address |
Dept. Nuclear Medicine, Shiri Saibaba Cancer Block, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9654007422 |
| Fax |
|
| Email |
sumeet.malapure@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self- DR Reena,
Shirdi saibaba cancer block, kasturba hospital, manipal 576104, udupi, karnataka, india
|
|
|
Primary Sponsor
|
| Name |
DR Reena Patil |
| Address |
Department of Health information management ,Manipal College of
Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Type of Sponsor |
Other [Self ( DR Reena Patil)] |
|
|
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 Reena |
Shirdi Saibaba cancer block, Kasturba Hospital, Manipal |
Room no:3
Department of Nuclear Medicine, shirdi Saibaba cancer block, Kasturba Hospital, Manipal, Udupi
576104, Karnataka
Udupi
KARNATAKA |
9008027890
reena.mchpmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2(Student Research) |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Records of the patients diagnosed with papillary thyroid carcinoma |
|
| ExclusionCriteria |
| Details |
Records of papillary thyroid carcinoma patients without Stimulated Thyroglobulin (Tg) values |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Train ML model to forecast papillary thyroid cancer recurrence effectively.
To pinpoint high-risk variables for papillary thyroid cancer recurrence. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="427"
Sample Size from India="427"
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)
|
27/05/2024 |
| 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="0"
Months="2"
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 data will be collected from the Nuclear Medicine department and Medical Records Department at Kasturba Hospital and extracted into a spreadsheet. · Following data extraction, data preprocessing is done to address the missing values or inconsistencies in the dataset. · After preprocessing the data, feature selection task will be carried out. · The extracted data will then be split into separate training and testing datasets. · Appropriate machine learning algorithms will be selected based on the features chosen from the dataset. · The model will be trained using the training dataset to learn patterns and relationships in the data. · After training, the model’s performance will be assessed using the validation dataset to ensure its accuracy. |