Breast CancerNCT04707287
Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer
An observational study of Breast Cancer, run by Liaquat University of Medical & Health Sciences at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 382 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- All patients diagnosed with breast cancer irrespective of age, gender and clinical stage
Who cannot join
- Any patient who lost to follow up
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Fazila Hashmi
Jāmshoro, Sindh
Fazila Hashmi, FCPS, 00923332608258
Fazila Hashmi, FCPS
- Not yet recruiting
Liaquat University of Medical and Health Sciences
Jāmshoro, 76090
Fazila Hashmi, FCPS
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- No Intervention
- Keywords
- Breast cancer, Sex steroid receptors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention used. This is observational study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathology of tumour
The incidence of grade and type of breast cancer at the time of study will be recorded and analysed
Measured: 6 months
Steroid receptor status
The concentrations of estrogen and progesterone receptor will be calculated and analysed.
Measured: 6 months
Secondary outcomes (3)
Age
The age of patient will be calculated and compared to the primary outcomes.
Measured: 6 months
State of menstruation
The onset of premenopausal and postmenopausal status of patient will be recorded
Measured: 6 months
Stage of tumour
The status of clinical and pathological stage of the breast cancer at the time of study will be analysed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jul 2020
- Primary completion1 Jan 2021
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazila Hashmi, Liaquat University of Medical & Health Sciences
- Investigators
- Fazila Hashmi, Principal investigator, Liaquat University of Medical and Health Sciences Jamshoro Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707287
- Sponsor's protocol ID
- LUMHS/REC/-17
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the moment the facility is undecided about the plans to share the data
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 16019385Folkerd 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 24074790Gambardella 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 29138989Stute 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 29384406Clendenen 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer
- ClinicalTrials.gov ID
- NCT04707287
- Acronym / sponsor ID
- LUMHS/REC/-17
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Sex steroid receptors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | Other: No InterventionAll the patients irrespective of age, ethnicity and stage of disease will be including once the disease is confirmed after triple assessment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients diagnosed with breast cancer irrespective of age, gender and clinical stage
Key exclusion criteria (1 listed)
- Any patient who lost to follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention used. This is observational study | Other | Breast Cancer Patients |
Primary outcome
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
Steroid receptor status
Time frame: 6 months
The concentrations of estrogen and progesterone receptor will be calculated and analysed.
3 secondary outcomes
Age
Time frame: 6 months
State of menstruation
Time frame: 6 months
Stage of tumour
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 16019385Gadducci 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.
- Background: PubMed 24074790Folkerd 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.
- Background: PubMed 29138989Gambardella 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.
- Background: PubMed 29384406Stute 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.
- Background: PubMed 30890167Clendenen 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.
- Individual participant dataSharing planned: Undecided. At the moment the facility is undecided about the plans to share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazila Hashmi principal investigator
Liaquat University of Medical and Health Sciences Jamshoro Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Liaquat University of Medical & Health Sciences at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fazila Hashmi, FCPS (00923332608258, fazilahashmi@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathology of tumour (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04707287, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.