Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
NIRAMAI Health Analytix Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Influence of patient characteristics on diagnostic accuracy of Thermalytix©. Patient characteristics will include: (a) Age (b) Lesion type (c) Pathologic diagnosis (d) Menopausal and hormonal status (e) Breast density (f) Family history (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 | — |
Countries
India
Contacts
Public ContactDr Geetha Manjunath
Regional Cancer Center (RCC), Thiruvananthapuram
Outcome results
None listed