A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer (Hypoxia)
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|ClinicalTrials.gov Identifier: NCT03797482|
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer Female||Procedure: Intra-operative Tumor Tissue Biopsy|
Three tumor samples will be obtained after the patient is under anaesthesia,
- Prior to starting surgery (Sample A)
- The middle intra-operative sample, which will be collected when half the tumour has been devascularized (i.e., somewhere midway during the surgery). (Sample B)
- A third post excision (anoxic sample C). These tumour tissue samples will be stored as snap frozen, in RNA later and as paraffin sections.
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 and stored for future genomic and proteonomic evaluations.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer|
|Actual Study Start Date :||November 27, 2017|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||November 30, 2022|
Intra-operative tumour tissue biopsies
Intra-operative tumour tissue biopsies will be collected for all patients
Procedure: Intra-operative Tumor Tissue Biopsy
The changing pattern of gene expression during surgery has never been studied. This could be an effect of acute hypoxia that sets in the tumour during surgery or could be a surgical response. To study these changes happening in the tumour during surgery, we are taking serial biopsies during surgery, one at the beginning, one midway during surgery and one at the end of surgery. These samples will be snap frozen and stored at -80 deg celsius in biorepository for future analysis.
Other Name: Breast cancer surgery
- Gene expression changes [ Time Frame: 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. ]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).
- Immunohistochemistry for other markers [ Time Frame: 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. ]The secondary outcome measured will be protein expression changes during surgical resection. Protein levels will be quantitated, and their levels evaluated, during different time-points of surgical resection. Transcripts found to be de-regulated or changed at different time-points of surgical resection will be evaluated using IHC at protein level. We will also use high throughput omics technologies (SILAC, ITRAQ) for characterising these changes at protein levels.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797482
|Contact: Shalaka Joshi, MS, MCh||9869089803 ext firstname.lastname@example.org|
|Contact: Rohini A Hawaldaremail@example.com|
|Tata Memorial Center||Recruiting|
|Mumbai, Maharashtra, India, 400012|
|Contact: Shalaka Joshi, MS, MCh 22241608601 ext 4265 firstname.lastname@example.org|
|Contact: Rohini A Hawaldar, BSc 09820432613 email@example.com|
|Principal Investigator:||Rajendra Badwe||Director, tata Memorial Centre|