Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer
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;
- see the relationship of sex steroid receptors with the histological grade of breast cancer.
- evaluate the efficacy of steroid receptors as a prognostic factor
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Jāmshoro, Pakistan, 76090
- Not yet recruiting
- Liaquat University of Medical and Health Sciences
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Contact:
- Fazila Hashmi, FCPS
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Sindh
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Jāmshoro, Sindh, Pakistan
- Recruiting
- Fazila Hashmi
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Contact:
- Fazila Hashmi, FCPS
- Phone Number: 00923332608258
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Principal Investigator:
- Fazila Hashmi, FCPS
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Sub-Investigator:
- Riaz Akhtar
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
|
No intervention used.
This is observational study
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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
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6 months
|
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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
|
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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.
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Fazila Hashmi, Liaquat University of Medical and Health Sciences Jamshoro Pakistan
Publications and helpful links
General Publications
- Gadducci A, Biglia N, Sismondi P, Genazzani AR. Breast cancer and sex steroids: critical review of epidemiological, experimental and clinical investigations on etiopathogenesis, chemoprevention and endocrine treatment of breast cancer. Gynecol Endocrinol. 2005 Jun;20(6):343-60. doi: 10.1080/09513590500128492.
- Folkerd E, Dowsett M. Sex hormones and breast cancer risk and prognosis. Breast. 2013 Aug;22 Suppl 2:S38-43. doi: 10.1016/j.breast.2013.07.007.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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