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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.

ICGA: Indian Cancer Genome ATLAS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045570
Enrollment
300
Registered
2022-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Sponsors

IGBI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To establish the mutational profile, gene expression pattern, copy number characterization, genome-wide epigenetic modification pattern, proteomic characterization and immune pro-filing in tumors from patients with newly diagnosed, previously untreated breast cancer of all receptor subtypes and pathological subtypes.Timepoint: 5 years, post target sample collection

Countries

India

Contacts

Public ContactYogesh Kembhavi

Tata Memorial Centre

sudeepgupta04@yahoo.com02224177201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026