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Status unknownNCT04707287Updated Jan 14, 2021

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

An observational study in Breast Cancer, sponsored by Liaquat University of Medical & Health Sciences. Status unknown at 2 sites in Pakistan. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Liaquat University of Medical & Health Sciences · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
382
Sex
All
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Study 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
Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • Sex steroid receptors
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 382 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any patient who lost to follow up
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
382 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherNo Intervention

    No intervention used. This is observational study

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What researchers measure

Primary outcomes

  1. Histopathology of tumour

    The incidence of grade and type of breast cancer at the time of study will be recorded and analysed

    Time frame: 6 months

  2. Steroid receptor status

    The concentrations of estrogen and progesterone receptor will be calculated and analysed.

    Time frame: 6 months

Secondary outcomes

  1. Age

    The age of patient will be calculated and compared to the primary outcomes.

    Time frame: 6 months

  2. State of menstruation

    The onset of premenopausal and postmenopausal status of patient will be recorded

    Time frame: 6 months

  3. Stage of tumour

    The status of clinical and pathological stage of the breast cancer at the time of study will be analysed.

    Time frame: 6 months

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Study locations

1 of 2 sites recruiting
  • Fazila Hashmi
    Jāmshoro, Sindh, Pakistan
    • Fazila Hashmi, FCPS · Contact · 00923332608258
    • Fazila Hashmi, FCPS · Principal investigator
    • Riaz Akhtar · Sub investigator
    Recruiting
  • Liaquat University of Medical and Health Sciences
    Jāmshoro, 76090, Pakistan
    • Fazila Hashmi, FCPS · Contact
    Not yet recruiting
08

References and documents

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. PubMed 16019385 ↗
  • 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. PubMed 24074790 ↗
  • 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. PubMed 29138989 ↗
  • 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. PubMed 29384406 ↗
  • 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. PubMed 30890167 ↗

Individual participant data

Plan to share: Undecided — At the moment the facility is undecided about the plans to share the data

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04707287
Lead sponsor
Liaquat University of Medical & Health Sciences
Responsible party
Fazila Hashmi (Assistant Professor, Liaquat University of Medical & Health Sciences) — Principal investigator
First posted
Jan 13, 2021
Start date
Jul 1, 2020
Primary completion
Jan 1, 2021
Completion
Jan 15, 2021 (estimated)
Last update
Jan 14, 2021

Study contacts

Fazila Hashmi, FCPS
Contact
fazilahashmi@ymail.com
00923332608258
Fazila Hashmi
principal investigator · Liaquat University of Medical and Health Sciences Jamshoro Pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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