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Trial Title:
Potential Clinical Utilities of Circulating Tumor DNA in Advanced HER2 Negative Gastric Cancer
NCT ID:
NCT05513144
Condition:
Gastric Cancer
Circulating Tumor DNA (ctDNA)
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
Circulating Tumor DNA
Prognosis
Therapy Response
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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 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.
Criteria for eligibility:
Study pop:
HER2 negative gastric cancer patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Male or female patients age 18 - 75.
2. 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.
3. HER2 status is confirmed by IHC/FISH. HER2 negative: IHC 0/1+ or IHC 2+ plus FISH
negative.
4. At least one measurable lesion should be confirmed by imaging examination.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
6. No concomitant other malignant tumor or treated malignant tumor within last five
years.
7. Eligible peripheral blood and tissue samples.
8. Willing to provide clinicopathological information and imaging information.
Exclusion Criteria:
1. Patients received systemic treatment before enrolled or finished adjuvant
chemotherapy less than 6 months.
2. With second primary malignant diseases.
3. HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH
positive.
4. No qualified paired tissue samples.
5. No complete clinicopathological information and follow-up.
6. Presence of any systemic illness incompatible with participation in the clinical
trial or inability to provide written informed consent.
7. Other situations assessed by investigator can disturb quality control of the
investigation.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First People's Hospital of Changzhou
Address:
City:
Changzhou
Zip:
213003
Country:
China
Status:
Recruiting
Contact:
Last name:
chen wu, Ph.D
Phone:
0519-68871192
Email:
chenwucz@163.com
Start date:
December 24, 2021
Completion date:
February 28, 2025
Lead sponsor:
Agency:
chenwu
Agency class:
Other
Source:
The First People's Hospital of Changzhou
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513144