CancerNCT05685524
Clinical Study of Pan-cancer DNA Methylation Test in Plasma
An observational study of Cancer, run by Wuhan Ammunition Life-tech Co., Ltd at 1 site in China.
Trial summary
We intend to establish an efficient method for plasma cfDNA extraction and Bisulfite transformation to facilitate the detection of DNA methylation status using multiplex fluorescence PCR. Meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- DNA methylation test
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 cases are planned for each cancer type, and the total number of samples in the cancer group is expected to be 2,000.The number of samples in the non-cancer group is expected to be 1000 cases。
Who may be able to join
- (1)age >= 18 years. (2) with high suspicion of cancer diagnosed by endoscopy, other imaging examinations, pathological examinations, etc.
- no treatment with radiotherapy or chemotherapy.
Who cannot join
- (1) received antineoplastic treatment such as radiation/chemotherapy. (2) not preserved as required. (3) contaminated or volume is insufficient. (4) unclear pathological results (5) incomplete patient information.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Dihan Zhou, +86 13871581074, words1846@hotmail.com
Yanteng Zhao, PhD
About this study
Official title: Development of Diagnostic Model for Multi-cancer Diagnosis Based on DNA Methylation Biomarkers
We intend to establish an efficient method for plasma cfDNA extraction and Bisulfite transformation to facilitate the detection of DNA methylation status using multiplex fluorescence PCR. Meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. Finally, we will provide a pan-cancer blood test that is easy to operate, low cost, accurate and easy to promote.
- Conditions
- Cancer
- Being tested
- DNA methylation test
- Keywords
- Colorectal cancer, Liver cancer, Squamous cell carcinoma of the head and neck, Esophageal carcinoma, Pancreatic cancer, Ovarian cancer, Bladder cancer, Cervical cancer, Lung cancer, Stomach cancer
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Liver Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation testDiagnostic test
Cell-free DNA were extracted from plasma collected from individuals of cancer and non-cancerous disease groups, then the DNA was bisulfite converted and tested by DNA methylation assay based on real-time PCR platform.
| Study group | Role | What they receive |
|---|---|---|
| Cancer group | Patients aged 18 years or older with high suspicion of cancer diagnosed by endoscopy, other imaging tests, pathological examinations, etc. The cancer types include liver cancer, head and neck squamous cell carcinoma, esophageal cancer, pancreatic cancer, ovarian cancer, colorectal cancer, bladder cancer, cervical cancer, lung cancer and stomach cancer. Receives: Diagnostic Test: DNA methylation test | |
| Non-cancer group | Composed by healthy individuals and patients with non-cancerous diseases including hemorrhoids, enteritis, gastritis, tuberculosis and other non-cancerous diseases. Receives: Diagnostic Test: DNA methylation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The reference standard is the results of histopathological tests
Measured: immediately after the procedure
Specificity
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jul 2022
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Ammunition Life-tech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685524
- Sponsor's protocol ID
- PanCa
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Q, Dong L, Zhang L, Zhang W, Zhang Y, Huang Y, Jin H, Yang H, Liu X, Zhao Y. Analytical and Diagnostic Performance of a Dual-Target Blood Detection Test for Hepatocellular Carcinoma. Cancer Rep (Hoboken). 2024 Sep;7(9):e70017. doi: 10.1002/cnr2.70017.
PubMed 39324668
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Diagnostic Model for Multi-cancer Diagnosis Based on DNA Methylation Biomarkers
- ClinicalTrials.gov ID
- NCT05685524
- Acronym / sponsor ID
- PanCa
- Conditions
- Cancer
- Keywords
- Colorectal cancer, Liver cancer, Squamous cell carcinoma of the head and neck, Esophageal carcinoma, Pancreatic cancer, Ovarian cancer, Bladder cancer, Cervical cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Wuhan Ammunition Life-tech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Jan 2023 (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.
We intend to establish an efficient method for plasma cfDNA extraction and Bisulfite transformation to facilitate the detection of DNA methylation status using multiplex fluorescence PCR. Meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. Finally, we will provide a pan-cancer blood test that is easy to operate, low cost, accurate and easy to promote.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer group | – | Diagnostic Test: DNA methylation testPatients aged 18 years or older with high suspicion of cancer diagnosed by endoscopy, other imaging tests, pathological examinations, etc. The cancer types include liver cancer, head and neck squamous cell carcinoma, esophageal cancer, pancreatic cancer, ovarian cancer, colorectal cancer, bladder cancer, cervical cancer, lung cancer and stomach cancer. |
| Non-cancer group | – | Diagnostic Test: DNA methylation testComposed by healthy individuals and patients with non-cancerous diseases including hemorrhoids, enteritis, gastritis, tuberculosis and other non-cancerous diseases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 cases are planned for each cancer type, and the total number of samples in the cancer group is expected to be 2,000.The number of samples in the non-cancer group is expected to be 1000 cases。
Key inclusion criteria (2 listed)
- (1)age >= 18 years. (2) with high suspicion of cancer diagnosed by endoscopy, other imaging examinations, pathological examinations, etc.
- no treatment with radiotherapy or chemotherapy.
Key exclusion criteria (1 listed)
- (1) received antineoplastic treatment such as radiation/chemotherapy. (2) not preserved as required. (3) contaminated or volume is insufficient. (4) unclear pathological results (5) incomplete patient information.
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 |
|---|---|---|
| DNA methylation testCell-free DNA were extracted from plasma collected from individuals of cancer and non-cancerous disease groups, then the DNA was bisulfite converted and tested by DNA methylation assay based on real-time PCR platform. | Diagnostic test | Cancer group, Non-cancer group |
Primary outcome
Sensitivity
Time frame: immediately after the procedure
The reference standard is the results of histopathological tests
Specificity
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 39324668Yang Q, Dong L, Zhang L, Zhang W, Zhang Y, Huang Y, Jin H, Yang H, Liu X, Zhao Y. Analytical and Diagnostic Performance of a Dual-Target Blood Detection Test for Hepatocellular Carcinoma. Cancer Rep (Hoboken). 2024 Sep;7(9):e70017. doi: 10.1002/cnr2.70017.
- 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.
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 Cancer, run by Wuhan Ammunition Life-tech Co., Ltd 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 2 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 17 Jan 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 Tingting Li, PhD (+8613317163670, litt@whammunition.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: immediately after the procedure). 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?
On the ClinicalTrials.gov record for NCT05685524, which also lists 1 linked publication.
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 17 Jan 2023.