Breast CancerNCT04302415
Metabolomics Explores Biomarkers for Metastatic Breast Cancer
An observational study of Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis. PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- There is no other intervention, only clinical treatment.
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Feb 2023
- How long will I take part?
- 5 Years
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
Who may be able to join
- Age: 18-70 yrs.
- Any menopausal status.
- Any hormone receptor status.
- Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
- Patients must have measurable disease, per RECIST criteria v1.1.21.
- Estimated life expectancy of ≥ 12 weeks.
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- Ability to swallow oral medications.
- Participants must have adequate organ function as defined by:
- ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L, haemoglobin ≥ 10 g/dL.
- creatinine < 1.5 x UNL (upper normal limit).
- Total bilirubin < 1.5x UNL.
- ALT \& AST < 2.5xUNL; alkaline phosphatase < 2.5xUNL.
- Creatine phosphokinase (CPK) ≤ 2.5 x UNL.
- Patients with CNS metastatic disease are allowed if the disease is controlled and stable for at least 3 months by CT or MRI.
Who cannot join
- Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
- History of other malignancies.
- No measureable lesion is present, as defined by RECIST 1.1.
- Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study.
- Concurrent interventional studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong
Fukai WANG, MM, 13335110772, wfk8664@126.com
About this study
Official title: Clinical Study of Metabolomics-based Approach Explore Biomarkers for Metastatic Breast Cancer
RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis.
PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.
Read the detailed description
Imaging evaluation of the effect of chemotherapy on patients with visceral metastases from breast cancer, metabolomics was used to analyze the changes of metabolites in plasma, and to find biomarkers that could reflect visceral metastasis and treatment effects. The purpose is to help clinicians predict whether patients have potential visceral metastases, evaluate the effects of visceral metastasis treatment, and reflect the patient's prognosis.
Patients with visceral metastases on imaging examinations received chemotherapy as planned, and blood samples were collected from patients before and during imaging assessments. Analysis of metabolites in plasma using ultra high performance liquid chromatography. Patient information were collected through medical record, including race, age, height and body mass index, menarche age, menstrual status, menopausal age (if applicable), tobacco and alcohol history, motherhood history, family history, etc.
- Conditions
- Breast Cancer
- Being tested
- There is no other intervention, only clinical treatment.
- Keywords
- metastatic breast cancer, metabolomics, biomarkers, Clinical study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no other intervention, only clinical treatment.Drug
There is no other intervention, only clinical treatment.
| Study group | Role | What they receive |
|---|---|---|
| only liver metastasis | There is no other intervention, only clinical treatment. Receives: Drug: There is no other intervention, only clinical treatment. | |
| only lung metastasis | There is no other intervention, only clinical treatment. Receives: Drug: There is no other intervention, only clinical treatment. | |
| only brain | There is no other intervention, only clinical treatment. | |
| No distant metastasis | There is no other intervention, only clinical treatment. Receives: Drug: There is no other intervention, only clinical treatment. | |
| More than two organs metastasis | There is no other intervention, only clinical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).
To assess the changes of metabolites during the process of our observation, and to find out the relationship between metabolite(s) and therapeutic effect.
Measured: up to six months
Secondary outcomes (2)
progression of disease
To observe the duration from the stable condition to progression of disease. Patients were followed up every six months in first five years, then followed up once a year.
Measured: Up to 10 years
overall survival
To observe the duration from the stable condition to death. Patients were followed up every six months in first five years, then followed up once a year.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Oct 2019
- Primary completion1 Mar 2020
- Study completion1 Feb 2023 (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.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
- Investigators
- YU Zhiyong, PhD, Study chair, Shandong Cancer Hospital and InstituteWANG Fukai, MM, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302415
- Sponsor's protocol ID
- OMICS Mark
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Metabolomics-based Approach Explore Biomarkers for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04302415
- Acronym / sponsor ID
- OMICS Mark
- Conditions
- Breast Cancer
- Keywords
- metastatic breast cancer, metabolomics, biomarkers, Clinical study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 10 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.
RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis.
PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.
Detailed description
Imaging evaluation of the effect of chemotherapy on patients with visceral metastases from breast cancer, metabolomics was used to analyze the changes of metabolites in plasma, and to find biomarkers that could reflect visceral metastasis and treatment effects. The purpose is to help clinicians predict whether patients have potential visceral metastases, evaluate the effects of visceral metastasis treatment, and reflect the patient's prognosis.
Patients with visceral metastases on imaging examinations received chemotherapy as planned, and blood samples were collected from patients before and during imaging assessments. Analysis of metabolites in plasma using ultra high performance liquid chromatography. Patient information were collected through medical record, including race, age, height and body mass index, menarche age, menstrual status, menopausal age (if applicable), tobacco and alcohol history, motherhood history, family history, etc.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| only liver metastasis | – | Drug: There is no other intervention, only clinical treatment.There is no other intervention, only clinical treatment. |
| only lung metastasis | – | Drug: There is no other intervention, only clinical treatment.There is no other intervention, only clinical treatment. |
| only brain | – | –There is no other intervention, only clinical treatment. |
| No distant metastasis | – | Drug: There is no other intervention, only clinical treatment.There is no other intervention, only clinical treatment. |
| More than two organs metastasis | – | –There is no other intervention, only clinical treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
Key inclusion criteria (14 listed)
- Age: 18-70 yrs.
- Any menopausal status.
- Any hormone receptor status.
- Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
- Patients must have measurable disease, per RECIST criteria v1.1.21.
Key exclusion criteria (5 listed)
- Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
- History of other malignancies.
- No measureable lesion is present, as defined by RECIST 1.1.
- Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study.
- Concurrent interventional studies.
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 |
|---|---|---|
| There is no other intervention, only clinical treatment.There is no other intervention, only clinical treatment. | Drug | No distant metastasis, only liver metastasis, only lung metastasis |
Primary outcome
Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).
Time frame: up to six months
To assess the changes of metabolites during the process of our observation, and to find out the relationship between metabolite(s) and therapeutic effect.
2 secondary outcomes
progression of disease
Time frame: Up to 10 years
overall survival
Time frame: Up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- 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.
YU Zhiyong, PhD study chair
Shandong Cancer Hospital and Institute
WANG Fukai, MM principal investigator
Shandong Cancer Hospital and Institute
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 Shandong Cancer Hospital and Institute 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 14 inclusion and 5 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 10 Mar 2020. 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 Zhiyong YU, PhD (86-13355312277, drzhiyongyu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS). (time frame: up to six months). 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 10 Mar 2020.