NCT04707287

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 11, 2021

Last Update Submit

January 13, 2021

Conditions

Breast Cancer

Keywords

Breast cancerSex steroid receptors

Outcome Measures

Primary Outcomes (2)

  • Histopathology of tumour

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

    6 months

  • Steroid receptor status

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

    6 months

Secondary Outcomes (3)

  • Age

    6 months

  • State of menstruation

    6 months

  • Stage of tumour

    6 months

Study Arms (1)

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

No InterventionOTHER

No intervention used. This is observational study

Breast Cancer Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Any patient who lost to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fazila Hashmi

Jāmshoro, Sindh, Pakistan

RECRUITING

Liaquat University of Medical and Health Sciences

Jāmshoro, 76090, Pakistan

NOT YET RECRUITING

Related Publications (5)

  • 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.

    PMID: 16019385BACKGROUND

  • 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.

    PMID: 24074790BACKGROUND

  • 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.

    PMID: 29138989BACKGROUND

  • 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.

    PMID: 29384406BACKGROUND

  • 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.

    PMID: 30890167BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fazila Hashmi

    Liaquat University of Medical and Health Sciences Jamshoro Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fazila Hashmi, FCPS

CONTACT

00923332608258fazilahashmi@ymail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

July 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 15, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations

PA(2)