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Collection and analysis of exhaled breath volatile organic compounds from breast cancer patients using Kozhnosys CanScan prototype, aiming to develop a machine-learning model.

Not Applicable
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Registration Number
CTRI/2024/02/063290
Lead Sponsor
Kozhnosys Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Inclusion Criteria for Test group (Breast Cancer group)

1. Willing to fill the informed consent form.

2. Female in the age group 20 to 80 years with/without common medical conditions like Hypertension, Hyperlipidaemia, Hypothyroidism, Arthritis, Asthma, GERD, Diabetes, PCOD, Vitamin D deficiency, Calcium Deficiency, Iron deficiency, Menopause, etc. (1)

3. Confirmed cases of breast cancer (Stage I-IV) as per positive mammogram report, positive tissue biopsy report and TNM staging done.

4.Confirmed cases of breast cancer but not exposed to any previous treatment cycle/surgery.

Inclusion Criteria for Control group

(1) Willing to fill the informed consent form.

(2) Female in the age group 20 to 80 years.

(3) Healthy subjects appearing for routine health check-up in hospital and having with negative mammogram and with/without common medical conditions like Hypertension, Hyperlipidemia, Hypothyroidism, Arthritis, Asthma, GERD, Diabetes, PCOD, Vitamin D deficiency, Calcium Deficiency, Iron deficiency, Menopause, Thyroid etc.

(4) Willing to undertake routine mammography test.

Exclusion Criteria

Exclusion Criteria for Test group (Breast Cancer group), Other cancer group and Control group

(1) Age group below 20 years.

(2) Any known illness within 2 weeks from breath collection.

(3) Already undergoing treatment for cancer.

(4) Undergone surgery for breast tumour removal.

(5) Positive, but no breast cancer on later investigation (Positive mammogram but negative biopsy report).

(6) Drinking and smoking habits.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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