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

• Conditions: Breast Cancer
• Interventions: Other: No Intervention

• Registration Number: NCT04707287
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

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

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 Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-01
• Primary Completion: 2021-01-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14
• Study Completion: 2021-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 382

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer Patients	No Intervention	All the patients irrespective of age, ethnicity and stage of disease will be including once the disease is confirmed after triple assessment

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Liaquat University of Medical and Health Sciences; 🇵🇰 Jāmshoro, Pakistan

Fazila Hashmi; 🇵🇰 Jāmshoro, Sindh, Pakistan