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Studying How Tumor Germs Influence the Spread of Aggressive Breast Cancer and Using Lab Tests to Detect Early Signs in Lymph Nodes

Investigate the Role of Tumor Microbiome on Metastatic Triple-Negative Breast Cancer Progression. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092895
Enrollment
165
Registered
2025-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Tata Memorial Hospital
Lead Sponsor
IIT Roorkee
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: The study population strictly includes diagnostically confirmed TNBC patients only. For the benign tissue, TNBC patients with benign tumors are the study population. For the control, healthy breast tissue adjacent to the tumor can be resected from the same patient or as per the convenience of the clinicians. For the lymph node tissue, TNBC patients with sentinel or axillary LN +ve patients are included. For the lymph node tissue control, axillary LN-ve tissue can be included.

Exclusion criteria

Exclusion criteria: The study population strictly includes diagnostically confirmed TNBC patients only. For the benign tissue, TNBC patients with benign tumors are the study population. For the control, healthy breast tissue adjacent to the tumor can be resected from the same patient or as per the convenience of the clinicians. For the lymph node tissue, TNBC patients with sentinel or axillary LN +ve patients are included. For the lymph node tissue control, axillary LN-ve tissue can be included.

Design outcomes

Primary

MeasureTime frame
A Biomarker that indicates the specific drug target might be used to select patients for a trial where PFS is the primary endpoint. If the biomarker is present, that means the treatment is most likely to be effective, and PFS might be longer.Timepoint: Samples from the past 5 years will be studied.

Secondary

MeasureTime frame
completely performed invitro with the cell lines. Only microbes will be isolated from the human tissue sample, and after isolation, the progression of breast cancer cell lines in the presence of tumor microbes will be performed through several in vitro assays. So, there is no requirement for any endpoints.Timepoint: Samples from the past 5 years will be studied.

Countries

India

Contacts

Public ContactDr Sushmita Rath

IIT Roorkee, Uttarakhand

rama_b@bt.iitr.ac.in9869154396

Outcome results

None listed

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