| CTRI Number |
CTRI/2019/07/020450 [Registered on: 30/07/2019] Trial Registered Prospectively |
| Last Modified On: |
26/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evauation of a new tool for early detection of breast cancer |
|
Scientific Title of Study
|
Evaluation of modified thermography as a tool for early detection of breast cancer in women attending breast clinic at NICPR |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roopa Hariprasad |
| Designation |
Scientist E |
| Affiliation |
National Institute of Cancer Prevention and Research |
| Address |
Room No 17, Ground floor, I-7, Sector 39, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09818278797 |
| Fax |
|
| Email |
roopaicmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Hariprasad |
| Designation |
Scientist E |
| Affiliation |
National Institute of Cancer Prevention and Research |
| Address |
Room No 17, Ground floor, I-7, Sector 39, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09818278797 |
| Fax |
|
| Email |
roopaicmr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Hariprasad |
| Designation |
Scientist E |
| Affiliation |
National Institute of Cancer Prevention and Research |
| Address |
Room No 17, Ground floor, I-7, Sector 39, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09818278797 |
| Fax |
|
| Email |
roopaicmr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Cancer Prevention and Research, I-7, Sector 39, Noida |
|
|
Primary Sponsor
|
| Name |
National Institute of Cancer Prevention and Research |
| Address |
I-7, Sector 39, Noida |
| Type of Sponsor |
Research institution |
|
|
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 Roopa Hariprasad |
National Institute of Cancer Prevention and Research |
Room No 17, I-7, SECTOR 39
Gautam Buddha Nagar
UTTAR PRADESH |
01202446932
roopaicmr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, NICPR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy women coming attending screening clinic |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mammography screening |
All Women who are enrolled in this study are sent to mammography and sonomammography correlation after thermoytix screening. All the results will be tabulated by an independent trial co-ordinator. |
| Intervention |
Thermalytix screening |
Thermalytix uses a series of deep learning models to pre-process 5 thermal images per subject, which then are passed to a feature extractor to extract 114 thermal abnormal patterns based on thermal distribution and asymmetry. A novel algorithm for extracting vascular structure and hotspot boundary is used to distinguish benign vs malignant conditions. As a final step, a machine learning classifier calibrated with results of mammography/sono-mammography and biopsy is used to generate a breast health score which can be used for automated triaging of patients in mass screening camps by health workers and the detailed report with annotated images can be used by radiologists for further diagnosis and prognosis of the disease. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 30 to 65 years attending breast clinic at NICPR will be included |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Lactating women
3. Women diagnosed with breast cancer
4. Women not able to provide consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity, specificity, negative and positive predictive values of Thermalytix® with mammography and/or cytology/core biopsy as the gold standard verification test |
At the end of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The agreement between the Thermalytix® and ultrasound/mammography diagnosis
2. Improvement in the PPV of CBE by Thermalytix® triaging
|
At the end of one year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
05/08/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary Objective: To estimate the sensitivity, specificity and predictive values of Thermalytix© in detecting breast cancers in the women attending breast clinic at NICPR against the age appropriate ‘gold-standard’ test USG/mammography and/or tissue diagnosis. Methodology The proposed study will be a prospective, comparative and blinded study to evaluate the effectiveness of the Thermalytix© when compared to the standard screening modalities in subjects. All subjects who arrive at the breast clinic will be first made to go through non-invasive Thermalytix® test, followed by clinical breast examination. Thermalytix® will be performed in a separate room assigned for it by a technician who is trained in performing this procedure. Women who are found to be suspicious of breast abnormalities in either of the tests are sent to mammography and sonomammography correlation. All the results will be tabulated by an independent trial co-ordinator. |