A study of a safe and non-invasive method for preventive screening for breast cancer and monitoring of breast cancer patients.
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2020/03/023783
- Lead Sponsor
- IRAMAI Health Analytix Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Women presenting with or without symptoms of breast cancer
2. Women with previous history of breast cancer or currently undergoing treatment for breast cancer who present for follow-up
3. Women who are willing to give written informed consent for study participation
4. Women who are ready to comply with the study related visits and procedures
Exclusion Criteria
1. Subjects who are pregnant
2. Subjects who are lactating
3. Subjects who have undergone Chemotherapy in the last 2 weeks at the time of study enrollment
4. Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of Thermalytix in asymptomatic and symptomatic women who have not been diagnosed earlier for breast cancerTimepoint: Every 6 months for 3 years
- Secondary Outcome Measures
Name Time Method Influence of patient characteristics on diagnostic accuracy of Thermalytix©. <br/ ><br>Patient characteristics will include: <br/ ><br>(a) Age <br/ ><br>(b) Lesion type <br/ ><br>(c) Pathologic diagnosis <br/ ><br>(d) Menopausal and hormonal status <br/ ><br>(e) Breast density <br/ ><br>(f) Family history <br/ ><br>(g) Other risk factorsTimepoint: 3 years;Performance of Thermalytix in women previously diagnosed with breast cancer.Timepoint: Every 6 months for 3 years;Recommend how Thermalytix can be used to complement standard breast cancer screening procedureTimepoint: 3 years