Clinical trial NCT04707287: Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer
Official title: Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast cancer
Sex steroid receptors
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 382
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Any patient who lost to follow up

Primary outcomes:
measure: Histopathology of tumour
timeFrame: 6 months
measure: Steroid receptor status
timeFrame: 6 months
Secondary outcomes:
measure: Age
timeFrame: 6 months
measure: State of menstruation
timeFrame: 6 months
measure: Stage of tumour
timeFrame: 6 months
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Fazila Hashmi
state: Sindh
city: Jāmshoro
country: Pakistan
facility: Liaquat University of Medical and Health Sciences
Study officials:
affiliation: Liaquat University of Medical and Health Sciences Jamshoro Pakistan
name: Fazila Hashmi
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gambardella A, Esposito D, Accardo G, Taddeo M, Letizia A, Tagliafierro R, Esposito K, Pasquali D. Sexual function and sex hormones in breast cancer patients. Endocrine. 2018 Jun;60(3):510-515. doi: 10.1007/s12020-017-1470-7. Epub 2017 Nov 14.
citation: Stute P, Wildt L, Neulen J. The impact of micronized progesterone on breast cancer risk: a systematic review. Climacteric. 2018 Apr;21(2):111-122. doi: 10.1080/13697137.2017.1421925. Epub 2018 Jan 31.
citation: Clendenen TV, Ge W, Koenig KL, Afanasyeva Y, Agnoli C, Brinton LA, Darvishian F, Dorgan JF, Eliassen AH, Falk RT, Hallmans G, Hankinson SE, Hoffman-Bolton J, Key TJ, Krogh V, Nichols HB, Sandler DP, Schoemaker MJ, Sluss PM, Sund M, Swerdlow AJ, Visvanathan K, Zeleniuch-Jacquotte A, Liu M. Breast cancer risk prediction in women aged 35-50 years: impact of including sex hormone concentrations in the Gail model. Breast Cancer Res. 2019 Mar 19;21(1):42. doi: 10.1186/s13058-019-1126-z.