Table 3.
Ongoing clinical trials using ctDNA in gastric cancer.
| Clinical Trials.Gov Identifier/Location | Study Design/ Patients |
Population | Aim | Detection Technique | ctDNA Sampling Timepoints | Primary Outcome Measure | End Date |
|---|---|---|---|---|---|---|---|
| Screening | |||||||
| Prospective observational | |||||||
|
NCT04947995 China |
Case control n = 450 |
Patients undergoing OGD-cancer, precancerous, or healthy control | To develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer | NGS | At OGD | Sensitivity and specificity of blood-based multi-omics assay for early detection of gastric cancer with comparison to OGD and/or histological diagnosis | June 2023 |
|
NCT04665687 South Korea |
Cohort n = 1730 |
Early GC, gastric adenoma | To identify whether tumour molecular profiling based on tissue or blood could be used for prediction of prognosis and diagnosis of early GC and precancerous gastric adenoma | NGS | At intervals up to 2 years | To identify biomarkers for differential diagnosis between early gastric cancer and precancerous adenoma including liquid biopsy | September 2022 |
|
NCT04511559 China |
Cohort n = 540 |
Patients with chronic gastritis, moderate to severe atrophy/metaplasia, or gastric cancer | To describe the profile of ctDNA methylation in gastric cancer To demonstrate correlation between ctDNA methylation status and prognosis |
DNA methylation | At OGD | ctDNA methylation status and correlation with early diagnosis and prognostic evaluation | May 2025 |
| Early-stage disease | |||||||
| Prospective observational | |||||||
|
NCT05027347 Vietnam |
Cohort n = 200 |
I-IIIA GC and healthy control | To develop a protocol for detection of ctDNA in plasma of patients with early-stage GC | NGS | Not specified | Sensitivity and specificity of mutation-based assay for detecting early-stage GC | September 2023 |
|
NCT05029869 Vietnam |
Cohort n = 100 |
Early-stage GC undergoing radical gastrectomy | To detect ctDNA as a biomarker to monitor MRD after radical gastrectomy | NGS | 14 days pre- and at scheduled intervals post-gastrectomy | Sensitivity and specificity of MRD detection using ctDNA | October 2025 |
|
NCT04943406 Italy |
Cohort n = 150 |
cT2 and/or N+ gastric or GOJ Siewert type II -III adenocarcinoma | To determine the prognostic role of liquid biopsy for detection of ctDNA in patients with locally advanced GC | Not specified | Pre- and post-operation, last cycle of adjuvant chemotherapy, or 3 months post-operation if there is no adjuvant chemotherapy recurrence | Prognostic impact of ctDNA positivity at recurrence or 3 year follow-up | May 2025 |
| Interventional | |||||||
|
NCT04510285 US |
Phase II–pilot n = 24 |
Patients that had HER2-positive oesophageal, GOJ, and gastric adenocarcinoma and completed standard-of-care surgery (R0) plus neoadjuvant or adjuvant therapy who are ctDNA-positive within 8 months of competing treatment |
To investigate whether trastuzumab plus pembrolizumab will improve clearance of tumour DNA after surgery | Not specified | Post-operation and then at scheduled intervals | Rate of ctDNA clearance at 6 months | August 2022 |
|
NCT03957564 China |
Phase II n = 40 |
>T1 and N+ resectable gastric/GOJ adenocarcinoma undergoing neoadjuvant chemotherapy and surgery | To explore the clinical value of dynamic detection of CTCs, ctDNA, and cfDNA To explore the relationship between detection and prognosis |
Not specified | Before and during neoadjuvant chemotherapy, 10 days after operation | Number and types of CTCs, mutation rate of ctDNA, and concentration of cfDNA pre- and post-neoadjuvant chemotherapy and surgery The relationship between tumour response and changes in numbers of CTCs and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and surgery |
May 2024 |
|
NCT04817826 Italy |
Phase II, multi-cohort n = 31 |
MSI-H gastric/GOJ (Siewert II, III) cancer eligible for radical surgery | To evaluate the activity and safety of combination tremelimumab and durvalumab as neoadjuvant (cohort 1) and definitive (cohort 2) treatment for MSI-high gastric/GOJ cancer | Not specified | Pre- and post-operation and at intervals up to year 5 | Cohort 1: pathological complete response (ypT0N0) and negative ctDNA status | April 2025 |
| Advanced disease | |||||||
| Prospective observational | |||||||
|
NCT04520295 China |
Cohort n = 100 |
HER2-positive advanced GC HER2-negative advanced GC control |
To identify molecular panel correlating with efficacy towards HER2-postitive GC To observe the molecular evolution of HER2-positive GC during treatment by ctDNA detection |
NGS | Baseline, first surveillance after treatment, progression | Change in baseline of molecular biomarkers at time of best overall response | May 2025 |
| Early and late-stage disease | |||||||
| Prospective observational | |||||||
|
NCT04576858 Denmark |
Cohort n = 1950 |
Cohorts 1 and 2: Perioperative and trimodality treatment Cohort 3: Definitive CRT Cohort 4: Palliative chemotherapy Cohort 5: Palliative treatment without the use of chemotherapy |
Clinical utility of plasma of ctDNA in OG cancer | Not specified | Intermittent intervals over a two-year period | Time until recurrence | July 2025 |
n, number; ctDNA, circulating tumour DNA; OGD, oesophago-gastro-duodenoscopy; GC, gastric cancer; MRD, minimal residual disease; GOJ, gastro-oesophageal junction; CTCs, circulating tumour cells; cfDNA, cell free DNA; MSI-H, microsatellite instability-high.