An Open Label, Single Centre Clinical Trial to assess the Clinical performance of CRISPR-CAS based sensing platform Assay in detecting Breast Cancer
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/01/048792
- Lead Sponsor
- Archeron Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Female patients aged 18 and above diagnosed with
Breast Cancer.
2. Able to provide blood sample (up to 10ml).
3. Patients ready to give written informed consent
and willing to comply with the study protocol.
Exclusion Criteria
1. Patients not eligible to give the required
blood sample in the opinion of the
investigator.
2. Pregnant or lactating females.
3. Presence of any severe medical or psychological
condition or chronic
condition/inflammation/infection that in the
opinion of the investigator would compromise
the patientâ??s safety or successful
participation in the study.
4. Patients undergoing chemotherapy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the specificity and sensitivity of CRISPR-CAS based sensing platform using the BRCA1- Cas12-Strip Assay to detect Breast CancerTimepoint: At Baseline only - onetime assessment.
- Secondary Outcome Measures
Name Time Method To assess the Cas12 specificity in combination with gRNA for the detection of single nucleotide polymorphism in breast cancer patientsTimepoint: At Baseline, one-time assessment only.