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Trial record 1 of 1 for:    11395851 [PUBMED-IDS]
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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
Sponsor:
Information provided by (Responsible Party):
Dr Rajendra A. Badwe, Tata Memorial Centre

Tracking Information
First Submitted Date June 28, 2018
First Posted Date January 9, 2019
Last Update Posted Date January 10, 2019
Actual Study Start Date November 27, 2017
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2019)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03797482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 4, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
Official Title A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
Brief Summary 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.
Detailed Description

Three tumor samples will be obtained after the patient is under anaesthesia,

  1. Prior to starting surgery (Sample A)
  2. 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)
  3. 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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Breast cancer tumor tissue
Sampling Method Non-Probability Sample
Study Population Women diagnosed with breast cancer at outpatient clinic
Condition Breast Cancer Female
Intervention 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
Study Groups/Cohorts Intra-operative tumour tissue biopsies
Intra-operative tumour tissue biopsies will be collected for all patients
Intervention: Procedure: Intra-operative Tumor Tissue Biopsy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 4, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2022
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women diagnosed with breast cancer, undergoing surgery upfront
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shalaka Joshi, MS, MCh 9869089803 ext 4265 drjoshishalaka@gmail.com
Contact: Rohini A Hawaldar 09820432613 rwhawaldar@gmail.com
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03797482
Other Study ID Numbers Protocol 254
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dr Rajendra A. Badwe, Tata Memorial Centre
Study Sponsor Tata Memorial Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Rajendra Badwe Director, tata Memorial Centre
PRS Account Tata Memorial Hospital
Verification Date June 2018