Breast CarcinomaNCT04316247
Demographic , Clinicopathological Characteristics and Survival of Breast Cancer
An observational study of Breast Carcinoma, run by Assiut University.
Trial summary
The investigators will retrospectively study the demographic , clinicopathological characteristics and survival of breast cancer patients admitted to Assiut University hospital from the year 2015 to 2019 Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 31 Dec 2024
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retrospective study on breast cancer patients : A single institution study
Who may be able to join
- All histologically confirmed and documented patients with invasive ductal or lobular carcinoma of the breast attending at Assiut University hospital from year 2015 to 2019.
Who cannot join
- • Patients who previously received treatment outside Assiut University hospital.
- A serious un controlled concomitant disease that would contraindicate with use of systemic treatment. .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Demographic, Clinicopathological Characteristics and Survival of Breast Cancer Patients in Assiut University Hospital (2015-2019).
The investigators will retrospectively study the demographic , clinicopathological characteristics and survival of breast cancer patients admitted to Assiut University hospital from the year 2015 to 2019
Read the detailed description
Breast cancer is one of the most common malignancies in females, which is the second leading cause of cancer death throughout the world after lung cancer . The incidence of breast cancer has been increasing over the past decades , especially in young women (≤ 35 years old). There is approximately 182,000 women with breast neoplasm annually in the United States, accounting for about 26% of all incident cancers among women.
In Asia, the morbidity rate is as high as 9.5%-12% . Even worse in China, the average onset age of breast cancer might be 8-10 years younger than that in Western countries which account for upto 4% in total breast cancer patients .
In Egypt, breast cancer is the commonest type of female malignancy represented about 38.8% among common cancer sites in females.Although The unclear etiology of the majority of breast cancer, but there are numerous risk factors for the disease. Screening and early detection when combined with adequate, efficient treatment is considered the hope for a reduction of mortality in breast cancer as postulated by World Health organization (WHO).
- Conditions
- Breast Carcinoma
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival rate of breast cancer in assiut university hospital
The number of patients survived after surgery or chemotherapy
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Apr 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Nageh Kamel Shalaby, Assiut University
- Investigators
- Samir E Shehata, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316247
- Sponsor's protocol ID
- Neveen
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen S, Chen H, Yi Y, Jiang X, Lei H, Luo X, Chen Y, Liu S, Yuan D, Jia X, Li J. Comparative study of breast cancer with or without concomitant Paget disease: An analysis of the SEER database. Cancer Med. 2019 Jul;8(8):4043-4054. doi: 10.1002/cam4.2242. Epub 2019 May 28.
PubMed 31134761
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic, Clinicopathological Characteristics and Survival of Breast Cancer Patients in Assiut University Hospital (2015-2019).
- ClinicalTrials.gov ID
- NCT04316247
- Acronym / sponsor ID
- Neveen
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 2020 (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.
The investigators will retrospectively study the demographic , clinicopathological characteristics and survival of breast cancer patients admitted to Assiut University hospital from the year 2015 to 2019
Detailed description
Breast cancer is one of the most common malignancies in females, which is the second leading cause of cancer death throughout the world after lung cancer . The incidence of breast cancer has been increasing over the past decades , especially in young women (≤ 35 years old). There is approximately 182,000 women with breast neoplasm annually in the United States, accounting for about 26% of all incident cancers among women.
In Asia, the morbidity rate is as high as 9.5%-12% . Even worse in China, the average onset age of breast cancer might be 8-10 years younger than that in Western countries which account for upto 4% in total breast cancer patients .
In Egypt, breast cancer is the commonest type of female malignancy represented about 38.8% among common cancer sites in females.Although The unclear etiology of the majority of breast cancer, but there are numerous risk factors for the disease. Screening and early detection when combined with adequate, efficient treatment is considered the hope for a reduction of mortality in breast cancer as postulated by World Health organization (WHO).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective study on breast cancer patients : A single institution study
Key inclusion criteria (1 listed)
- All histologically confirmed and documented patients with invasive ductal or lobular carcinoma of the breast attending at Assiut University hospital from year 2015 to 2019.
Key exclusion criteria (2 listed)
- • Patients who previously received treatment outside Assiut University hospital.
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
The survival rate of breast cancer in assiut university hospital
Time frame: One year
The number of patients survived after surgery or chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Results publication: PubMed 31134761Chen S, Chen H, Yi Y, Jiang X, Lei H, Luo X, Chen Y, Liu S, Yuan D, Jia X, Li J. Comparative study of breast cancer with or without concomitant Paget disease: An analysis of the SEER database. Cancer Med. 2019 Jul;8(8):4043-4054. doi: 10.1002/cam4.2242. Epub 2019 May 28.
- Individual participant dataSharing planned: Undecided
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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.
Samir E Shehata, Professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Assiut University.
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 2 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 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Neveen N Kamel, doctor (+201287668559, neveenemanuel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survival rate of breast cancer in assiut university hospital (time frame: One year). 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 NCT04316247, which also lists 1 linked publication.
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 23 Mar 2020.