Breast CancerNCT04145960
Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer
An observational study of Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2019to Mar 2025
- How long will I take part?
- 3 Months
- 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 Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients with high risk of recurrence and metastasis of breast cancer
Who may be able to join
- Female
- Postoperative pathology confirmed invasive breast cancer after surgery for breast tumors
- Breast cancer-related chemotherapy and radiotherapy completed
- axillary lymph node metastasis ≥ 4
- age ≤ 60 years old
Who cannot join
- Male
- Aged above 60
- Breast Carcinoma in situ
- Women in pregnancy or breastfeeding
- Suffering from other malignant tumors
- Non-compliant patient
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Yali Xu, +86-13717761030, 49950757@qq.com
About this study
Official title: Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer Via Analysis of Immunoinflammation-related Protein Complexes in Blood
The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied.
Read the detailed description
200 patients with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.
- Conditions
- Breast Cancer
- 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 |
|---|---|---|
| Lymph node metastasis | Axillary lymph node metastasis ≥ 4 Lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune inflammation-related protein complexes
The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography.
Measured: 2 years
blood markers
The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start25 Apr 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2025 (estimated)
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.
- More trials run by Peking Union Medical College HospitalThe 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
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yali XU, Peking Union Medical College Hospital
- Investigators
- Yali Xu, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145960
- Sponsor's protocol ID
- PUMCH-BC500
- Status last verified
- Nov 2019
- First submitted
- 12 Aug 2019
- Last updated
- 18 Nov 2019
- Results posted
- 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 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer Via Analysis of Immunoinflammation-related Protein Complexes in Blood
- ClinicalTrials.gov ID
- NCT04145960
- Acronym / sponsor ID
- PUMCH-BC500
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 31 Oct 2019 (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 relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied.
Detailed description
200 patients with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymph node metastasis | – | –Axillary lymph node metastasis ≥ 4 Lymph nodes |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with high risk of recurrence and metastasis of breast cancer
Key inclusion criteria (5 listed)
- Female
- Postoperative pathology confirmed invasive breast cancer after surgery for breast tumors
- Breast cancer-related chemotherapy and radiotherapy completed
- axillary lymph node metastasis ≥ 4
- age ≤ 60 years old
Key exclusion criteria (6 listed)
- Male
- Aged above 60
- Breast Carcinoma in situ
- Women in pregnancy or breastfeeding
- Suffering from other malignant tumors
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
immune inflammation-related protein complexes
Time frame: 2 years
The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography.
blood markers
Time frame: 2 years
The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- 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.
Yali Xu principal investigator
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, run by Peking Union Medical College Hospital 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 5 inclusion and 6 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 18 Nov 2019. 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 Yali Xu (+86-13717761030, 49950757@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immune inflammation-related protein complexes (time frame: 2 years). 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 18 Nov 2019.