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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

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.

Condition or disease Intervention/treatment
Breast Cancer Female Procedure: Intra-operative Tumor Tissue Biopsy

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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
Breast cancer tumor tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women diagnosed with breast cancer, undergoing surgery upfront
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with breast cancer at outpatient clinic
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

Information from the National Library of Medicine

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


Contacts
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Contact: Shalaka Joshi, MS, MCh 9869089803 ext 4265 drjoshishalaka@gmail.com
Contact: Rohini A Hawaldar 09820432613 rwhawaldar@gmail.com

Locations
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India
Tata Memorial Center Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Shalaka Joshi, MS, MCh    22241608601 ext 4265    drjoshishalaka@gmail.com   
Contact: Rohini A Hawaldar, BSc    09820432613    rwhawaldar@gmail.com   
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
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Principal Investigator: Rajendra Badwe Director, tata Memorial Centre

Publications:
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Responsible Party: Dr Rajendra A. Badwe, Director, Tata Memorial Centre and Professor, Department of Surgical Oncology, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT03797482     History of Changes
Other Study ID Numbers: Protocol 254
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Hypoxia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms