Breast CancerNCT05417048
Clinical Study of Glycosylated Extracellular Vesicles for Early Diagnosis of Breast Cancer
An observational study of Breast Cancer, run by Peking University at 1 site in China.
Trial summary
This is a prospective, single-center, non-randomized, cohort study designed to evaluate the clinical diagnostic performance of glycosylated extracellular vesicles and their contents for early detection of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood Sample
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2022to 15 Jun 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breat cancer, Benign breast disease and Healthy control
Who may be able to join
- Patients≥18 years old；
- Histologically confirmed breast cancer patients，Benign breast disease （ig. breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst）or No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)
- Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments.
- Subjects signed informed consent；
Who cannot join
- A history of prior or concomitant malignancies;
- advanced stage breast cancer (stage IV)；
- Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
- Pregnant or lactating women ；
- Suspected or confirmed lesion was surgically removed；
- Patients with incomplete clinical data；
Show all 9Show fewer
- Patients with poor compliance；
- Patients with severe mental illness；
- Patients had received blood transfusions during one month一；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhaoqing Fan, +86-10-88197838, zhqfan@sina.com
Zhaoqing Fan, MD
About this study
Official title: miRNAs of Circulating Glycosylated Extracellular Vesicles as Biomarkers for Early Diagnosis of Breast Cancer Patients
This is a prospective, single-center, non-randomized, cohort study designed to evaluate the clinical diagnostic performance of glycosylated extracellular vesicles and their contents for early detection of breast cancer.
Read the detailed description
Early screening technology can improve the survival rate of breast cancer patients. Traditional mammography and ultrasonography have limitations on performance in clinical practice. Extracellular vesicles, one of the three major resources of liquid biopsy, contain multi-omics information that can be used to discover effective biomarkers for early diagnosis and screening of cancers.
In this study, we are going to isolate glycosylated extracellular vesicles from serum of cancer patients and non-cancer people with the novel GlyExo-Capture technology, and perform miRNA sequencing to selected out breast cancer-related markers. Then an early diagnosis model of breast cancer based on the GlyExo-Capture platform is able to be established using machine learning techniques and validated by qPCR experiments.
- Conditions
- Breast Cancer
- Being tested
- Blood Sample
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleDiagnostic test
Up to 5mL of blood via venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Breat cancer | Histologically confirmed breast cancer patients(Stage I-III) Receives: Diagnostic Test: Blood Sample | |
| Benign breast disease | Histologically confirmed breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst etc Receives: Diagnostic Test: Blood Sample | |
| Healthy control | No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI) Receives: Diagnostic Test: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic performance of the blood assay for differentiating benign and malignant breast disease using glycosylated extracellular vesicles analysis
The efficacy of the blood-based assay comparing with patholgic diagnosis, the gold standard, and imaging diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start14 Jul 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Jun 2024 (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 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
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Glyexo Gene Technology Co., Ltd.
- Responsible party
- Principal investigator, Tao OUYANG, Peking University
- Investigators
- Zhaoqing Fan, MD, Principal investigator, Breast center at Peking University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417048
- Sponsor's protocol ID
- BC-P31
- Status last verified
- Feb 2023
- First submitted
- 6 Jun 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miRNAs of Circulating Glycosylated Extracellular Vesicles as Biomarkers for Early Diagnosis of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05417048
- Acronym / sponsor ID
- BC-P31
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Beijing Glyexo Gene Technology Co., Ltd.
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 14 Jun 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 is a prospective, single-center, non-randomized, cohort study designed to evaluate the clinical diagnostic performance of glycosylated extracellular vesicles and their contents for early detection of breast cancer.
Detailed description
Early screening technology can improve the survival rate of breast cancer patients. Traditional mammography and ultrasonography have limitations on performance in clinical practice. Extracellular vesicles, one of the three major resources of liquid biopsy, contain multi-omics information that can be used to discover effective biomarkers for early diagnosis and screening of cancers.
In this study, we are going to isolate glycosylated extracellular vesicles from serum of cancer patients and non-cancer people with the novel GlyExo-Capture technology, and perform miRNA sequencing to selected out breast cancer-related markers. Then an early diagnosis model of breast cancer based on the GlyExo-Capture platform is able to be established using machine learning techniques and validated by qPCR experiments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breat cancer | – | Diagnostic Test: Blood SampleHistologically confirmed breast cancer patients(Stage I-III) |
| Benign breast disease | – | Diagnostic Test: Blood SampleHistologically confirmed breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst etc |
| Healthy control | – | Diagnostic Test: Blood SampleNo breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breat cancer, Benign breast disease and Healthy control
Key inclusion criteria (4 listed)
- Patients≥18 years old；
- Histologically confirmed breast cancer patients，Benign breast disease （ig. breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst）or No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)
- Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments.
- Subjects signed informed consent；
Key exclusion criteria (9 listed)
- A history of prior or concomitant malignancies;
- advanced stage breast cancer (stage IV)；
- Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
- Pregnant or lactating women ；
- Suspected or confirmed lesion was surgically removed；
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 |
|---|---|---|
| Blood SampleUp to 5mL of blood via venipuncture | Diagnostic test | Benign breast disease, Breat cancer, Healthy control |
Primary outcome
The diagnostic performance of the blood assay for differentiating benign and malignant breast disease using glycosylated extracellular vesicles analysis
Time frame: 24 months
The efficacy of the blood-based assay comparing with patholgic diagnosis, the gold standard, and imaging diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
Zhaoqing Fan, MD principal investigator
Breast center at Peking University Cancer Hospital
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 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 4 inclusion and 9 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 Feb 2023. 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 Zhaoqing Fan, MD (+86-10-88197838, zhqfan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic performance of the blood assay for differentiating benign and malignant breast disease using glycosylated extracellular vesicles analysis (time frame: 24 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 23 Feb 2023.