Breast NeoplasmsNCT06591039
A Multicenter Prospective Observational Cohort Based on a Breast Cancer Medical Record Database in China
An observational study of Breast Neoplasms, run by Fudan University at 1 site in China.
Trial summary
1. To construct a prospective, multi-center breast cancer treatment cohort in China, and analyze the factors affecting breast cancer diagnosis and treatment. 2. To evaluate the diagnosis and treatment and prognosis of breast cancer among patients in different regions and hospitals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- The study did not involve intervention in the patient's treatment regimen
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2025
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with malignant breast tumors
Who may be able to join
- Patients with malignant breast tumors must be diagnosed by cytology or histology, and their pathological types include but are not limited to breast carcinoma in situ, invasive carcinoma, and breast sarcoma.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
Jiong Wu, M.D, 862164175590, wujiong1122@vip.sina.com
Benlong Yang, Ph.D., 862164175590, yblqhdx@163.com
About this study
Official title: A Multicenter Prospective Observational Cohort Study of Breast Cancer Based on a Breast Cancer Medical Record Database in China
- To construct a prospective, multi-center breast cancer treatment cohort in China, and analyze the factors affecting breast cancer diagnosis and treatment.
- To evaluate the diagnosis and treatment and prognosis of breast cancer among patients in different regions and hospitals.
Read the detailed description
This research aims to:
- Understand and analyze the current status of breast cancer diagnosis and treatment; B. Publish an annual report on diagnosis and treatment; C. Data sharing, dynamic evaluation; D. Evaluate consensus and guideline promotion and implementation effects; E. Propose and set clinical quality standards for industry associations, and propose improvement goals; F. Provide a basis for industry associations to formulate specialized training programs; G. To provide assistance in the formulation of health insurance policies; H. Provide a platform for clinical research on breast cancer; I. Provide evidence for the formulation of clinical guidelines and consensus
- Conditions
- Breast Neoplasms
- Being tested
- The study did not involve intervention in the patient's treatment regimen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study did not involve intervention in the patient's treatment regimenProcedure or surgery
This study is based on a prospective database platform to register the occurrence, treatment and prognosis of breast cancer in China, so there is no clear exposure factor. This study was a prospective cohort study, which did not intervene in exposure factors, but only assessed the occurrence, treatment, and prognosis of breast cancer in China.
What is being measured
The primary outcome is the main question the study is designed to answer.
The current status of patients diagnosed with breast cancer and their types of treatment
Including but not limited to the patient receiving different surgical methods, different drugs, neoadjuvant and adjuvant therapy, etc.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Prognostic outcomes of patients
Including patient disease-free survival and overall survival.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (2)
Prognosis-recurrence-free survival
The time from the diagnosis of breast cancer to the recurrence or metastasis of the patient, and the parts involved.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Prognosis-overall survival
As the time from diagnosis of breast cancer to death of the patient
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong Wu, Fudan University
- Investigators
- Jiong Wu, M.D, Principal investigator, Cancer Hospital/ Institute, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591039
- Sponsor's protocol ID
- ATOSSA-001
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Cohort Study of Breast Cancer Based on a Breast Cancer Medical Record Database in China
- ClinicalTrials.gov ID
- NCT06591039
- Acronym / sponsor ID
- ATOSSA-001
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
- To construct a prospective, multi-center breast cancer treatment cohort in China, and analyze the factors affecting breast cancer diagnosis and treatment.
- To evaluate the diagnosis and treatment and prognosis of breast cancer among patients in different regions and hospitals.
Detailed description
This research aims to:
- Understand and analyze the current status of breast cancer diagnosis and treatment; B. Publish an annual report on diagnosis and treatment; C. Data sharing, dynamic evaluation; D. Evaluate consensus and guideline promotion and implementation effects; E. Propose and set clinical quality standards for industry associations, and propose improvement goals; F. Provide a basis for industry associations to formulate specialized training programs; G. To provide assistance in the formulation of health insurance policies; H. Provide a platform for clinical research on breast cancer; I. Provide evidence for the formulation of clinical guidelines and consensus
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with malignant breast tumors
Key inclusion criteria (1 listed)
- Patients with malignant breast tumors must be diagnosed by cytology or histology, and their pathological types include but are not limited to breast carcinoma in situ, invasive carcinoma, and breast sarcoma.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| The study did not involve intervention in the patient's treatment regimenThis study is based on a prospective database platform to register the occurrence, treatment and prognosis of breast cancer in China, so there is no clear exposure factor. This study was a prospective cohort study, which did not intervene in exposure factors, but only assessed the occurrence, treatment, and prognosis of breast cancer in China. | Procedure or surgery | – |
Primary outcome
The current status of patients diagnosed with breast cancer and their types of treatment
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Including but not limited to the patient receiving different surgical methods, different drugs, neoadjuvant and adjuvant therapy, etc.
Prognostic outcomes of patients
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Including patient disease-free survival and overall survival.
2 secondary outcomes
Prognosis-recurrence-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Prognosis-overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Jiong Wu, M.D principal investigator
Cancer Hospital/ Institute, Fudan University
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 Neoplasms, run by Fudan University at 1 site in China.
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 19 Sep 2024. 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 China. 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 Jiong Wu, M.D (+862164175590 ext. 88607, wujiong1122@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The current status of patients diagnosed with breast cancer and their types of treatment (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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?
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 19 Sep 2024.