Lung CancerNCT06363123
Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis
An observational study of Lung Cancer and Breast Cancer, run by Beijing Friendship Hospital at 4 sites in China.
Trial summary
The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Breast Cancer, Colorectal Cancer
- How many people
- 2,700 participants
- Where
- 4 sitesChina
- Study dates
- 29 Mar 2024to Apr 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population included a range of cancer patients and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.
Who may be able to join
- Multi-Cancer Group:
- Patients with a confirmed diagnosis based on the clinical "gold standard".
- Collection of plasma samples prior to treatment.
- Availability of complete clinical data.
- Control Group:
- Individuals with no abnormalities in routine physical examinations and relevant clinical tests.
- Age ≥ 45 years.
- Availability of complete clinical data.
Who cannot join
- Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
- Coexistence of other systemic tumors.
- Absence of plasma sample collection before treatment.
- Pregnancy status.
- No clear evidence of histopathological diagnosis (not applicable to the control group based on this criterion).
- Patients with severe acute infections.
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- Patients with severe anemia.
- Patients with severe liver or kidney dysfunction.
- Patients with autoimmune deficiency diseases.
- Patients with Hyperlipidemia.
- Patients received contrast agent injection before blood draw.
- Patients with psychiatric disorders.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yibin Xie, Ph.D.
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Li Min, Ph. D., +86 13552652141, minli@ccmu.edu.cn
Bilian Kang, Ph.D., +86 18001218793, kbl@mail.ccmu.edu.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Qian Song, Ph.D.
- Recruiting
Hebei Tumor Hospital
Shijiazhuang, Hebei, 050010
Lianmei Zhao, Ph.D.
About this study
Official title: Identification and Validation of Plasma Diagnostic Biomarkers for Multi-Cancer Based on Metabolomics: A Multi-Center Clinical Research and Validation Trial
The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of multi-cancer.
Read the detailed description
Firstly, a wide-targeted metabolomic measurement will be conducted on all samples to identify potential metabolite candidate markers and analyze differences in the metabolic profiles of patients with different types of cancer. Additionally, a comprehensive metabolite database specific to cancer patients will be constructed.
Secondly, Samples will be randomly allocated into modeling and testing cohorts. The modeling cohort will be further divided into training and validation sets. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high diagnostic efficacy for cancer.
Ultimately, the testing cohort will be used to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.
- Conditions
- Lung Cancer, Breast Cancer, Colorectal Cancer, Thyroid Cancer, Gastric Cancer, Cervical Cancer
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Thyroid Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms, Liver Neoplasms, Pancreatic 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 |
|---|---|---|
| Multi-cancer group | Patients diagnosed with cancer, including lung cancer，breast cancer，colorectal cancer，thyroid cancer，gastric cancer，cervical cancer，liver cancer，pancreatic cancer，cholangiocarcinoma，prostate cancer，esophageal cancer，ovarian cancer，renal cell carcinoma. | |
| control group | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma metabolite content
The outcome will be tested by metabolomics detection technology based on mass spectrometry
Measured: Before receiving treatment for cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start29 Mar 2024
- Primary completionOct 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Retrospective
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Li, Beijing Friendship Hospital
- Investigators
- Li Min, Ph.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363123
- Sponsor's protocol ID
- BFHHZML20240009
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Apr 2024
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Plasma Diagnostic Biomarkers for Multi-Cancer Based on Metabolomics: A Multi-Center Clinical Research and Validation Trial
- ClinicalTrials.gov ID
- NCT06363123
- Acronym / sponsor ID
- BFHHZML20240009
- Conditions
- Lung Cancer, Breast Cancer, Colorectal Cancer, Thyroid Cancer, Gastric Cancer, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Apr 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.
The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of multi-cancer.
Detailed description
Firstly, a wide-targeted metabolomic measurement will be conducted on all samples to identify potential metabolite candidate markers and analyze differences in the metabolic profiles of patients with different types of cancer. Additionally, a comprehensive metabolite database specific to cancer patients will be constructed.
Secondly, Samples will be randomly allocated into modeling and testing cohorts. The modeling cohort will be further divided into training and validation sets. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high diagnostic efficacy for cancer.
Ultimately, the testing cohort will be used to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-cancer group | – | –Patients diagnosed with cancer, including lung cancer，breast cancer，colorectal cancer，thyroid cancer，gastric cancer，cervical cancer，liver cancer，pancreatic cancer，cholangiocarcinoma，prostate cancer，esophageal cancer，ovarian cancer，renal cell carcinoma. |
| control group | – | –Healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included a range of cancer patients and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.
Key inclusion criteria (8 listed)
- Multi-Cancer Group:
- Control Group:
Key exclusion criteria (12 listed)
- Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
- Coexistence of other systemic tumors.
- Absence of plasma sample collection before treatment.
- Pregnancy status.
- No clear evidence of histopathological diagnosis (not applicable to the control group based on this criterion).
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
Plasma metabolite content
Time frame: Before receiving treatment for cancer
The outcome will be tested by metabolomics detection technology based on mass spectrometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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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.
Li Min, Ph.D. principal investigator
Beijing Friendship Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Breast Cancer, run by Beijing Friendship Hospital at 4 sites 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 8 inclusion and 12 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Li Min, Ph.D. (+86 13552652141, minli@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma metabolite content (time frame: Before receiving treatment for cancer). 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 15 Apr 2024.