Gastric CancerNCT05647941
Neo-adjuvant Chemotherapy Evluation in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1
An observational study of Gastric Cancer and Chemotherapy Effect, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Chemotherapy Effect
- What is being tested?
- Detection of levels of circulating EV-derived lncRNA-GC1
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Community Sample Shanxi - Hospital and community sample Beijing -Hospital
Who may be able to join
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- radiographically identified as advanced 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.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital Ethics Committee
Beijing, Beijing Municipality, 100853
XinXin Wang, MD, 86-13354879656, wangxinxin@sina.com
About this study
Official title: Non-invasive Response Assessment of Neo-adjuvant Chemotherapy in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1
The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer.
Read the detailed description
The LncRNA-GC1could noninvasively track dynamics of tumor burden and has been proposed as a real-time biomarker that can provide both predictive and prognostic values. But the value in monitoring the neo-adjuvant chemotherapy response is unclear. The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a monitoring biomarker for patients with gastric cancer receiving neo-adjuvant chemotherapy.
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Being tested
- Detection of levels of circulating EV-derived lncRNA-GC1
- Keywords
- Circulating exosomal lncRNA-GC1, Advanced Gastric Carcinoma, treatment response
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of levels of circulating EV-derived lncRNA-GC1Diagnostic test
For patients with gastric cancer receiving neo-adjuvant chemotherapy, the dynamic changes of EV-derived lncRNA-GC1 was detected to identify whether is can serve as a monitoring biomarker for treatment response.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of levels of circulating exosomal lncRNA-GC1
Levels of circulating exosomal lncRNA-GC1 are detected by RT-PCR
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jan 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647941
- Sponsor's protocol ID
- neo-Biomarker
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared until the final results published.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Response Assessment of Neo-adjuvant Chemotherapy in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1
- ClinicalTrials.gov ID
- NCT05647941
- Acronym / sponsor ID
- neo-Biomarker
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Keywords
- Circulating exosomal lncRNA-GC1, Advanced Gastric Carcinoma, treatment response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Dec 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.
The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer.
Detailed description
The LncRNA-GC1could noninvasively track dynamics of tumor burden and has been proposed as a real-time biomarker that can provide both predictive and prognostic values. But the value in monitoring the neo-adjuvant chemotherapy response is unclear. The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a monitoring biomarker for patients with gastric cancer receiving neo-adjuvant chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample Shanxi - Hospital and community sample Beijing -Hospital
Key inclusion criteria (4 listed)
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- radiographically identified as advanced 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 |
|---|---|---|
| Detection of levels of circulating EV-derived lncRNA-GC1For patients with gastric cancer receiving neo-adjuvant chemotherapy, the dynamic changes of EV-derived lncRNA-GC1 was detected to identify whether is can serve as a monitoring biomarker for treatment response. | Diagnostic test | – |
Primary outcome
Detection of levels of circulating exosomal lncRNA-GC1
Time frame: Through study completion, an average of 1 year
Levels of circulating exosomal lncRNA-GC1 are detected by RT-PCR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Undecided. Data may be shared until the final results published.
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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 Gastric Cancer and Chemotherapy Effect, run by Chinese PLA General Hospital 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 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of levels of circulating exosomal lncRNA-GC1 (time frame: Through study completion, an average of 1 year). 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 14 Dec 2022.