Stomach NeoplasmsNCT06776835
Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer
An observational study of Stomach Neoplasms, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Analysis of relative quantitative of small non-coding RNAs
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2023to Nov 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AFFILIATED HOSPITAL OF NANTONG UNIVERSITY
Who may be able to join
- Having signed informed consent
- Age≥ 18 years old and ≤ 85 years old
- Histologically confirmed gastric cancer
Who cannot join
- Other previous malignancy within 5 year
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
- Pregnancy or lactation period
- Legal incapacity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer and Exploring Its Correlation With Prognostic Diagnosis
Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early. Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as an auxiliary diagnostic biomarker for gastric cancer.
Read the detailed description
Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early.
Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated by previous scientific researches that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as a new biomarker panel for gastric cancer.
The purpose of the present clinical trail is to explore the correlation between small non-coding RNAs panel and early gastric cancer, and to elucidate the possibility of small non-coding RNAs panel as a biomarker for gastric cancer. Verify the experimental purpose by monitoring the relative quantification of small non-coding RNAs panel through high-throughput sequencing and qRT PCR technology.
- Conditions
- Stomach Neoplasms
- Being tested
- Analysis of relative quantitative of small non-coding RNAs
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of relative quantitative of small non-coding RNAsDiagnostic test
Each participant was enrolled to assess the of relative quantitative of small non-coding RNAs
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer cases from medical centers in China | Measurement of levels of circulating small non-coding RNAs Receives: Diagnostic Test: Analysis of relative quantitative of small non-coding RNAs | |
| Controls from medical centers in China | Measurement of levels of circulating small non-coding RNAs Receives: Diagnostic Test: Analysis of relative quantitative of small non-coding RNAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of relative quantitative of small non-coding RNAs
Relative quantitative of small non-coding RNAs are detected by quantitative RT-PCR
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start10 Dec 2023
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776835
- Sponsor's protocol ID
- 2023-L166
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer and Exploring Its Correlation With Prognostic Diagnosis
- ClinicalTrials.gov ID
- NCT06776835
- Acronym / sponsor ID
- 2023-L166
- Conditions
- Stomach Neoplasms
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Jan 2025 (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.
Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early. Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as an auxiliary diagnostic biomarker for gastric cancer.
Detailed description
Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early.
Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated by previous scientific researches that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as a new biomarker panel for gastric cancer.
The purpose of the present clinical trail is to explore the correlation between small non-coding RNAs panel and early gastric cancer, and to elucidate the possibility of small non-coding RNAs panel as a biomarker for gastric cancer. Verify the experimental purpose by monitoring the relative quantification of small non-coding RNAs panel through high-throughput sequencing and qRT PCR technology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer cases from medical centers in China | – | Diagnostic Test: Analysis of relative quantitative of small non-coding RNAsMeasurement of levels of circulating small non-coding RNAs |
| Controls from medical centers in China | – | Diagnostic Test: Analysis of relative quantitative of small non-coding RNAsMeasurement of levels of circulating small non-coding RNAs |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AFFILIATED HOSPITAL OF NANTONG UNIVERSITY
Key inclusion criteria (3 listed)
- Having signed informed consent
- Age≥ 18 years old and ≤ 85 years old
- Histologically confirmed gastric cancer
Key exclusion criteria (4 listed)
- Other previous malignancy within 5 year
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
- Pregnancy or lactation period
- Legal incapacity
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 |
|---|---|---|
| Analysis of relative quantitative of small non-coding RNAsEach participant was enrolled to assess the of relative quantitative of small non-coding RNAs | Diagnostic test | Controls from medical centers in China, Gastric cancer cases from medical centers in China |
Primary outcome
Analysis of relative quantitative of small non-coding RNAs
Time frame: an average of 2 years
Relative quantitative of small non-coding RNAs are detected by quantitative RT-PCR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stomach Neoplasms, run by Affiliated Hospital of Nantong 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of relative quantitative of small non-coding RNAs (time frame: an average of 2 years). 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 Jan 2025.