A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
ConditionBreast Cancer Female
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTata Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically diagnosis of breast cancer (by FNAC or Biopsy)
Not received any chemotherapy or surgical intervention except core biopsy.
Planed for Breast cancer surgery
Willing to give consent for the study
Disqualifiers
Clinically diagnosis of Metastatic breast cancer
Received any anticancer therapy
Trial population
Women diagnosed with breast cancer at outpatient clinic
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Intra-operative Tumor Tissue Biopsy
Procedure/SurgeryThe 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Intra-operative tumour tissue biopsies1 intervention
Trial outcomes
Primary outcomes
1
Gene expression changes
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).
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.Secondary outcomes
1
Immunohistochemistry for other markers
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tata Memorial Hospital
Lead sponsor
Tata Memorial Centre
Sponsor institution
Source ClinicalTrials.gov