Gastric CancerNCT05513144
Potential Clinical Utilities of Circulating Tumor DNA in Advanced HER2 Negative Gastric Cancer
An observational study of Gastric Cancer and Circulating Tumor DNA (ctDNA), run by chenwu at 1 site in China.
Trial summary
This study aims to evaluate the use of next generation sequencing (NGS) to detect circulating tumor DNA in advanced HER2 negative gastric cancer patients. The evaluation of the therapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Circulating Tumor DNA (ctDNA)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2021to 28 Feb 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER2 negative gastric cancer patients
Who may be able to join
- Male or female patients age 18 - 75.
- Histologically confirmed adenocarcinoma of gastric or gastro-oesophageal junction. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
- HER2 status is confirmed by IHC/FISH. HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.
- At least one measurable lesion should be confirmed by imaging examination.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- No concomitant other malignant tumor or treated malignant tumor within last five years.
- Eligible peripheral blood and tissue samples.
- Willing to provide clinicopathological information and imaging information.
Who cannot join
- Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
- With second primary malignant diseases.
- HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive.
- No qualified paired tissue samples.
- No complete clinicopathological information and follow-up.
- Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
- Other situations assessed by investigator can disturb quality control of the investigation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
chen wu, Ph.D, 0519-68871192, chenwucz@163.com
About this study
Official title: Monitoring Circulating Tumor DNA and Evaluating Prognostic and Predictive Impact of Liquid Biopsy in Advanced HER2 Negative Gastric Cancer
This study aims to evaluate the use of next generation sequencing (NGS) to detect circulating tumor DNA in advanced HER2 negative gastric cancer patients. The evaluation of the therapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. In this study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.
Read the detailed description
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. More than 80% of gastric cancer are in advanced stage.
Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. Detecting ctDNA, in most patients, allows for the noninvasive molecular characterization detection of tumors, including genetic changes that are revealed by the selective pressure of therapies. Considering the origin of ctDNA, it can be from different subclones of primary tumor or both primary and metastatic tumors, the ctDNA may overcome the problems caused by tumor heterogeneity. Additionally, the short half-life of ctDNA, about 2 hours, makes ctDNA an ideal dynamic marker of tumor bulk.
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform using ctDNA collected from peripheral blood samples of gastric cancer patients. Samples will be collected at baseline, every two months in the surveillance after treatment and disease progression.
Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of tumor response according to the tumor DNA circulating assessment in gastric cancer treatment, in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be continued uselessly, (ii) and to allow a early changing to an alternative therapy regimen.
- Conditions
- Gastric Cancer, Circulating Tumor DNA (ctDNA)
- Keywords
- Gastric Cancer, Circulating Tumor DNA, Prognosis, Therapy Response
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic molecular markers.
Change from baseline in molecular biomarkers at time on disease progression
Measured: 2 years
The sensitivity and specificity of ctDNA detection. Profiling of the most frequently detected gene mutations and level of mutations in ctDNA
Measured: 2 years
Secondary outcomes (4)
Mutation profile and the concordance of mutations in tumor tissue and ctDNA of gastric cancer
Measured: 2 years
Mechanisms of therapy resistance
Screening out the molecular markers related to the therapy resistance of gastric cancer by comparing molecular profiles on baseline and disease progression of patients with different therapy response
Measured: 2 years
The concordance and accuracy of response evaluation results determined by ctDNA compared with imaging and serum tumor biomarkers (CEA, CA19-9,CA72-4 et al).
Measured: 2 years
Relative frequency of targetable mutations (incl. TMB and MSI status).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start24 Dec 2021
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- chenwu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, chenwu, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513144
- Sponsor's protocol ID
- 2022-CL048-01
- Status last verified
- Feb 2023
- First submitted
- 21 Aug 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Circulating Tumor DNA and Evaluating Prognostic and Predictive Impact of Liquid Biopsy in Advanced HER2 Negative Gastric Cancer
- ClinicalTrials.gov ID
- NCT05513144
- Acronym / sponsor ID
- 2022-CL048-01
- Conditions
- Gastric Cancer, Circulating Tumor DNA (ctDNA)
- Keywords
- Gastric Cancer, Circulating Tumor DNA, Prognosis, Therapy Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- chenwuUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 24 Aug 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 study aims to evaluate the use of next generation sequencing (NGS) to detect circulating tumor DNA in advanced HER2 negative gastric cancer patients. The evaluation of the therapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. In this study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.
Detailed description
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. More than 80% of gastric cancer are in advanced stage.
Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. Detecting ctDNA, in most patients, allows for the noninvasive molecular characterization detection of tumors, including genetic changes that are revealed by the selective pressure of therapies. Considering the origin of ctDNA, it can be from different subclones of primary tumor or both primary and metastatic tumors, the ctDNA may overcome the problems caused by tumor heterogeneity. Additionally, the short half-life of ctDNA, about 2 hours, makes ctDNA an ideal dynamic marker of tumor bulk.
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform using ctDNA collected from peripheral blood samples of gastric cancer patients. Samples will be collected at baseline, every two months in the surveillance after treatment and disease progression.
Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of tumor response according to the tumor DNA circulating assessment in gastric cancer treatment, in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be continued uselessly, (ii) and to allow a early changing to an alternative therapy regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 negative gastric cancer patients
Key inclusion criteria (8 listed)
- Male or female patients age 18 - 75.
- Histologically confirmed adenocarcinoma of gastric or gastro-oesophageal junction. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
- HER2 status is confirmed by IHC/FISH. HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.
- At least one measurable lesion should be confirmed by imaging examination.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (7 listed)
- Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
- With second primary malignant diseases.
- HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive.
- No qualified paired tissue samples.
- No complete clinicopathological information and follow-up.
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
Prognostic molecular markers.
Time frame: 2 years
Change from baseline in molecular biomarkers at time on disease progression
The sensitivity and specificity of ctDNA detection. Profiling of the most frequently detected gene mutations and level of mutations in ctDNA
Time frame: 2 years
4 secondary outcomes
Mutation profile and the concordance of mutations in tumor tissue and ctDNA of gastric cancer
Time frame: 2 years
Mechanisms of therapy resistance
Time frame: 2 years
The concordance and accuracy of response evaluation results determined by ctDNA compared with imaging and serum tumor biomarkers (CEA, CA19-9,CA72-4 et al).
Time frame: 2 years
Relative frequency of targetable mutations (incl. TMB and MSI status).
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
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 Circulating Tumor DNA (ctDNA), run by chenwu 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 8 inclusion and 7 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 6 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 chen wu (+86-519-68871192, chenwucz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic molecular markers. (time frame: 2 years). 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?
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 6 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.