Breast CancerNCT05463276
The Characteristics and Risk Factors of Breast Cancer Patients Trend Distinctive Regional Differences: a Cross-sectional Study
An observational study of Breast Cancer and Breast Neoplasms, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial summary
This cross-sectional study, conducted at the Sindh Institute of Urology and Transplantation (SIUT), involved a retrospective data review of all the patients diagnosed with breast cancer from March 2017 to December 2021. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Invasive
- How many people
- 690 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2022to 1 May 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All breast cancer patients registered at the Breast Clinic, at the Sindh Institute of Urology and Transplantation (SIUT), Karachi from March 2017 till December 2021 were included
Who may be able to join
- All patients diagnosed with breast cancer
Who cannot join
- The patients that were lost to follow-up after the first consultation and those consulting for a second opinion were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
This cross-sectional study, conducted at the Sindh Institute of Urology and Transplantation (SIUT), involved a retrospective data review of all the patients diagnosed with breast cancer from March 2017 to December 2021. The demographic characteristics, clinical presentation, stage of the disease, and histopathological characteristics were analyzed.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Invasive, Breast Cancer Stage, Breast Cancer Metastatic
- Keywords
- Breast cancer, Clinical audit, Breast cancer risk factors, Breast cancer screening, Clinicopathological characterisitics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics of patients with breast cancer
age, gender, residence, marital status
Measured: At the time of presentation
Risk factors of patients with breast cancer
age at menarche, menopause, parity, breastfeeding, contraception, family history, body mass index
Measured: At the time of presentation
Clinical presentation of patients with breast cancer
site and duration
Measured: At the time of presentation
Stage of the breast cancer
American Joint Committee on Cancer (AJCC) Anatomic Stage Groups for breast cancer
Measured: At the time of presentation
Histopathological characteristics of patients with breast cancer
tumor type, hormone receptor status, Ki-67, and grade
Measured: At the time of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start28 Feb 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murk Niaz, Sindh Institute of Urology and Transplantation
- Investigators
- Murk Niaz, Principal investigator, Sindh Institute of Urology and TransplantationBushra Shirazi, Principal investigator, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463276
- Sponsor's protocol ID
- Breast Audit
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics and Risk Factors of Breast Cancer Patients Trend Distinctive Regional Differences: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05463276
- Acronym / sponsor ID
- Breast Audit
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Invasive, Breast Cancer Stage, Breast Cancer Metastatic
- Keywords
- Breast cancer, Clinical audit, Breast cancer risk factors, Breast cancer screening, Clinicopathological characterisitics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 18 Jul 2022 (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.
This cross-sectional study, conducted at the Sindh Institute of Urology and Transplantation (SIUT), involved a retrospective data review of all the patients diagnosed with breast cancer from March 2017 to December 2021. The demographic characteristics, clinical presentation, stage of the disease, and histopathological characteristics were analyzed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All breast cancer patients registered at the Breast Clinic, at the Sindh Institute of Urology and Transplantation (SIUT), Karachi from March 2017 till December 2021 were included
Key inclusion criteria (1 listed)
- All patients diagnosed with breast cancer
Key exclusion criteria (1 listed)
- The patients that were lost to follow-up after the first consultation and those consulting for a second opinion were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic characteristics of patients with breast cancer
Time frame: At the time of presentation
age, gender, residence, marital status
Risk factors of patients with breast cancer
Time frame: At the time of presentation
age at menarche, menopause, parity, breastfeeding, contraception, family history, body mass index
Clinical presentation of patients with breast cancer
Time frame: At the time of presentation
site and duration
Stage of the breast cancer
Time frame: At the time of presentation
American Joint Committee on Cancer (AJCC) Anatomic Stage Groups for breast cancer
Histopathological characteristics of patients with breast cancer
Time frame: At the time of presentation
tumor type, hormone receptor status, Ki-67, and grade
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Murk Niaz principal investigator
Sindh Institute of Urology and Transplantation
Bushra Shirazi principal investigator
Sindh Institute of Urology and Transplantation
1 site 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 and Breast Neoplasms, run by Sindh Institute of Urology and Transplantation at 1 site 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: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic characteristics of patients with breast cancer (time frame: At the time of presentation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022.