Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer

January 13, 2021 updated by: Fazila Hashmi, Liaquat University of Medical & Health Sciences

Null hypothesis: Histological grade of tumour bears no relation with the status of sex hormone receptors.

Alternate hypothesis: Both the histological grade of tumour and expression of sex steroid receptors are directly related to each other The investigators aim to;

  1. see the relationship of sex steroid receptors with the histological grade of breast cancer.
  2. evaluate the efficacy of steroid receptors as a prognostic factor

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Breast cancer accounts for the largest number of deaths amongst the female population worldwide. It is now considered as a systemic disease even if diagnosed at an initial stage, as the clinical behaviour cannot be accurately predicted. Due to this reason, it is subjected to new dimensions of research every day. The aggressiveness of the cancer is directly proportional to the histopathological grade at the time of diagnosis. This is true with reference to the clinical stage at the time of presentation, the probability to metastasize and potential to recur. The idea of steroids receptor expression by the tumour is not new, and to evaluate their status prior to the induction of hormone therapy is a must.

The sex steroids, which are produced intratumorally, include estrogen, progesterone, and androgens. They act on their specific receptors present on the cell surface, within the cytoplasm and at the nuclear membrane. It is a measurement of these receptors that decide the potential of an individual to respond to different types of hormones like estrogen receptor blockers and aromatase inhibitors. Do the histological grade of tumour bears some relation with the status of these receptors and can investigators predict and rely just on the cellular behaviour of tumour for the purpose of prognosis is still under investigation. This study is designed to see the relationship between the histopathological grade of the tumour with the expression of sex steroid receptors. It will also try to evaluate whether these receptors bear some prognostic value or not.

Study Type

Observational

Enrollment (Anticipated)

382

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Jāmshoro, Pakistan, 76090
        • Not yet recruiting
        • Liaquat University of Medical and Health Sciences
        • Contact:
          • Fazila Hashmi, FCPS
    • Sindh
      • Jāmshoro, Sindh, Pakistan
        • Recruiting
        • Fazila Hashmi
        • Contact:
          • Fazila Hashmi, FCPS
          • Phone Number: 00923332608258
        • Principal Investigator:
          • Fazila Hashmi, FCPS
        • Sub-Investigator:
          • Riaz Akhtar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients irrespective of age, gender and stage of disease will be including once the disease is confirmed after triple assessment. We shall cover the population in the southern part of Pakistan.

Description

Inclusion Criteria:

  • All patients diagnosed with breast cancer irrespective of age, gender and clinical stage

Exclusion Criteria:

  • Any patient who lost to follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Patients
All the patients irrespective of age, ethnicity and stage of disease will be including once the disease is confirmed after triple assessment
Other: No Intervention
No intervention used. This is observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathology of tumour
Time Frame: 6 months
The incidence of grade and type of breast cancer at the time of study will be recorded and analysed
6 months
Steroid receptor status
Time Frame: 6 months
The concentrations of estrogen and progesterone receptor will be calculated and analysed.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 6 months
The age of patient will be calculated and compared to the primary outcomes.
6 months
State of menstruation
Time Frame: 6 months
The onset of premenopausal and postmenopausal status of patient will be recorded
6 months
Stage of tumour
Time Frame: 6 months
The status of clinical and pathological stage of the breast cancer at the time of study will be analysed.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat University of Medical & Health Sciences

Investigators

  • Principal Investigator: Fazila Hashmi, Liaquat University of Medical and Health Sciences Jamshoro Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Anticipated)

January 15, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUMHS/REC/-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At the moment the facility is undecided about the plans to share the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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