A study to develop comprehensive database of molecular profiles (a form of testing that classifies tumors based on this genetic make-up) of cancer prevalent in Indian populations.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/09/045570
- Lead Sponsor
- IGBI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of Indian origin/ethnicity
2.Patients with histopathological proven invasive breast cancer of any pathological subtype.
3.Female patients who are older than 18 years of age.
4.Patients who are willing to provide written informed consent for participating in the study.
5.Patients with tumor of any estrogen
receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) status by immunochemistry (IHC).
Patients who have HER2 IHC 2+ tumor will be included, if in situ hybridisation (ISH) for HER2 amplification has or can be been performed.
6. Patients with bilateral cancer. Such cases would be considered as two separate tumors (if both samples are available).
7. Patients with contralateral cancer (Sample would be considered as new tumor).
8.Patients who have newly diagnosed treatment naïve breast cancer (tumor biopsy from primary
or metastatic tumor) OR who have received neoadjuvant/adjuvant chemotherapy and/or endocrine therapy (sample from primary tumor)
1.Patients who are not of Indian origin/ethnicity
2.Patients, who are unwilling to provide informed consent for
participating in the study.
3.Patients who, in the opinion of the investigator, are not reliable for
follow up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the molecular characterization of breast cancer tumors of all subtypes in a prospective cohort of Indian patients using multi-omic technologies.Timepoint: 60 months, post target sample collection
- Secondary Outcome Measures
Name Time Method To establish the mutational profile, gene expression pattern, copy number <br/ ><br>characterization, genome-wide epigenetic modification pattern, proteomic characterization and immune pro-filing in tumors from patients with newly diagnosed, previously untreated <br/ ><br>breast cancer of all receptor subtypes and pathological subtypes.Timepoint: 5 years, post target sample collection