Clinical trial · Observational
A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
NCT03797482CI-TRIAL-00094844HypoxiarecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during the surgery after partial devascularisation (sample B) and stored for future genomic and proteonomic evaluations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative Tumor Tissue Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intra-operative tumour tissue biopsies
- description
- Intra-operative tumour tissue biopsies will be collected for all patients
- interventionNames
- Procedure: Intra-operative Tumor Tissue Biopsy
Primary outcomes (1)
- measure
- Gene expression changes
- timeFrame
- The study aims to evaluate gene expression changes during surgical resection, which lasts for 30-90 minutes on an average. Thus, we have not planned a clinical follow-up or collection of data for the patients post sampling during surgical resection.
- description
- The primary outcome measured will be gene expression changes during surgical resection. Messenger ribonucleic acid (mRNA) transcripts will be quantitated and their levels evaluated during different time-points of surgical resection, using high throughput omics technologies (Next generation sequencing, nanostring ncounter, qRT-PCR array).
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinically diagnosis of breast cancer (by FNAC or Biopsy) 2. Not received any chemotherapy or surgical intervention except core biopsy. 3. Planed for Breast cancer surgery 4. Willing to give consent for the study Exclusion Criteria: 1. Clinically diagnosis of Metastatic breast cancer 2. Received any anticancer therapy
References
Publications (4)
- BACKGROUNDSemenza GL. Cancer-stromal cell interactions mediated by hypoxia-inducible factors promote angiogenesis, lymphangiogenesis, and metastasis. Oncogene. 2013 Aug 29;32(35):4057-63. doi: 10.1038/onc.2012.578. Epub 2012 Dec 10. PMID 23222717
- BACKGROUNDHockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41. PMID 11395851
- BACKGROUNDHoesel B, Schmid JA. The complexity of NF-kappaB signaling in inflammation and cancer. Mol Cancer. 2013 Aug 2;12:86. doi: 10.1186/1476-4598-12-86. PMID 23915189
- DERIVEDGardi N, Chaubal R, Gandhi KA, Kadam A, Singh A, Raja AS, Vanmali V, Hawaldar R, Sale S, Joshi S, Badwe R, Gupta S. Clinically actionable alterations in Indian breast cancer patients derived through whole transcriptome sequencing. Indian J Med Res. 2026 Jan;163(1):95-103. doi: 10.25259/IJMR_1642_2024. PMID 41934415