Gastric CancerNCT04000425
Potential Clinical Utilities of Circulating Tumor DNA in Gastric Cancer
An observational study of Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is designed to evaluate the potential clinical utility of ctDNA in the field of gastric cancer treatment,especially the usage of an indicator of MRD(minimal residual disease) in post radical gastrectomy patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- AVENIO ctDNA surveillance kit
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 May 2021
- 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
- Adult, Older adult
Study population: Stomach adenocarcinoma patients who plan to receive radical gastrectomy and continuous circulating tumor DNA monitoring
Who may be able to join
- Male or female patients age 18 - 75.
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
- Histologically proven primary stomach adenocarcinoma with Lauren type by gastroscopic biopsy before operation.
- Clinical stage is cT3/4N+M0 and the tumor is resectable in initial evaluation.
- No preoperative tumor therapy, including chemotherapy, radiotherapy, et al.
- No concomitant other malignant tumor or treated malignant tumor within last five years.
- Signed informed consent.
- Consent to provide research blood/tissue samples and clinicopathological information.
Who cannot join
- Radical gastrectomy was found cannot be achieved during operation due to metastasis or adjacent organ invasion.
- Only preoperative or postoperative blood sample was harvest or qualified.
- No qualified paired tissue samples.
- No complete clinicopatholoical information and follow-up.
- Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, 200032
Zhaoqing Tang, MD, tang.zhaoqing@zs-hospital.sh.cn
About this study
Official title: Evaluating Potential Clinical Utilities of Circulating Tumor DNA in Gastric Cancer
This study is designed to evaluate the potential clinical utility of ctDNA in the field of gastric cancer treatment,especially the usage of an indicator of MRD(minimal residual disease) in post radical gastrectomy patients. The primary purpose of this trial is to demonstrate if the postoperative ctDNA analysis could be used as an indicator of MRD or adjuvant chemotherapy response in advanced gastric cancer after radical gastrectomy.The second purpose is to describe the profile of ctDNA in gastric cancer.
Read the detailed description
Gastric cancer is an important health problem, being the fifth most common cancer and the third leading cause of cancer related death worldwide.Incidence shows clear regional and sex variations-rates are highest in Eastern Asia, Eastern Europe, and South America and lowest in Northern and Southern Africa. In China, gastric cancer accounts for nearly 16% of all malignant tumors and more than 80% of gastric cancer are in advanced stage.
Minimal residual disease (MRD) was proposed to describe the remaining tumor cells after treatment with curative intent. For curable gastric cancer, MRD means residential cancer cells after radical gastrectomy which share phenotypic similarity and genetic heritage with the original tumor. Treating MRD can increase the rates of cure had been supported by the experience of using adjuvant therapy for some type of solid tumor (for example, colorectal cancer, breast cancer). The challenge in monitoring the MRD in gastric cancer patients is that there is no very sensitive method. Computed tomography(CT) and blood tumor markers are either difficult to detect peritonial dissemination, the most frequent recurrent pattern in gastric caner or with limited sensitivity and specificity.
Tumor-specific DNA mutations detected in the cell-free component of peripheral blood, which is known as circulating tumor DNA (ctDNA), in most patients, allow for the noninvasive molecular characterization detection of tumors, including genetic changes that are revealed by the selective pressure of adjuvant 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.
In summary, the ctDNA is a good candidate to be a new kind of blood tumor marker. The preliminary studies had shown very good prospects in some tumors, including breast caner and colon cancer.But little was known in gastric cancer, so we designed this study to demonstrate the potential clinical utility of ctDNA in the field of gastric cancer treatment, especially the usage of an indicator of MRD in post radical gastrectomy patients.
- Conditions
- Gastric Cancer
- Being tested
- AVENIO ctDNA surveillance kit
- Keywords
- Gastric Cancer, Circulating Tumor DNA, Minimal Residue Disease, Chemotherapy 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.
AVENIO ctDNA surveillance kitCombination product
AVENIO circulating tumor DNA (ctDNA) Analysis Kits is a portfolio of three next-generation sequencing (NGS) liquid biopsy assay kits for oncology research: the AVENIO ctDNA Targeted Kit, Expanded Kit and Surveillance Kit.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA detection | The blood samples for ctDNA and other tumor markers (such as CEA, et al.) will be first collected within 7 days before surgery, and then be tested after radical gastrectomy in scheduled interval. Receives: Combination Product: AVENIO ctDNA surveillance kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of disease recurrence risk according to first positive ctDNA detection
Time is measured from first positive ctDNA detection to disease-free survival event.
Measured: 2 years
Description of ctDNA changing to adjuvant chemotherapy response
For subjects with postoperative positive ctDNA, time is measured from first adjuvant chemotherapy to first negative ctDNA detection.
Measured: 2 years
Secondary outcomes (2)
Leading time between ctDNA detection and disease recurrence detected by conventional methods
Time is measured between first positive ctDNA detection and first recurrence detected by conventional methods.
Measured: 2 years
The ctDNA level/mutations in gastric cancer preoperatively
Profiling of the most frequently detected gene mutations and level of mutations in preoperative ctDNA.
Measured: Within 7 days before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Dec 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion31 May 2021 (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 Shanghai Zhongshan 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
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaoqing Tang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000425
- Sponsor's protocol ID
- ZSGC-005
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 27 Jun 2019
- 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 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Potential Clinical Utilities of Circulating Tumor DNA in Gastric Cancer
- ClinicalTrials.gov ID
- NCT04000425
- Acronym / sponsor ID
- ZSGC-005
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Circulating Tumor DNA, Minimal Residue Disease, Chemotherapy Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 27 Jun 2019 (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 is designed to evaluate the potential clinical utility of ctDNA in the field of gastric cancer treatment,especially the usage of an indicator of MRD(minimal residual disease) in post radical gastrectomy patients. The primary purpose of this trial is to demonstrate if the postoperative ctDNA analysis could be used as an indicator of MRD or adjuvant chemotherapy response in advanced gastric cancer after radical gastrectomy.The second purpose is to describe the profile of ctDNA in gastric cancer.
Detailed description
Gastric cancer is an important health problem, being the fifth most common cancer and the third leading cause of cancer related death worldwide.Incidence shows clear regional and sex variations-rates are highest in Eastern Asia, Eastern Europe, and South America and lowest in Northern and Southern Africa. In China, gastric cancer accounts for nearly 16% of all malignant tumors and more than 80% of gastric cancer are in advanced stage.
Minimal residual disease (MRD) was proposed to describe the remaining tumor cells after treatment with curative intent. For curable gastric cancer, MRD means residential cancer cells after radical gastrectomy which share phenotypic similarity and genetic heritage with the original tumor. Treating MRD can increase the rates of cure had been supported by the experience of using adjuvant therapy for some type of solid tumor (for example, colorectal cancer, breast cancer). The challenge in monitoring the MRD in gastric cancer patients is that there is no very sensitive method. Computed tomography(CT) and blood tumor markers are either difficult to detect peritonial dissemination, the most frequent recurrent pattern in gastric caner or with limited sensitivity and specificity.
Tumor-specific DNA mutations detected in the cell-free component of peripheral blood, which is known as circulating tumor DNA (ctDNA), in most patients, allow for the noninvasive molecular characterization detection of tumors, including genetic changes that are revealed by the selective pressure of adjuvant 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.
In summary, the ctDNA is a good candidate to be a new kind of blood tumor marker. The preliminary studies had shown very good prospects in some tumors, including breast caner and colon cancer.But little was known in gastric cancer, so we designed this study to demonstrate the potential clinical utility of ctDNA in the field of gastric cancer treatment, especially the usage of an indicator of MRD in post radical gastrectomy patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ctDNA detection | – | Combination Product: AVENIO ctDNA surveillance kitThe blood samples for ctDNA and other tumor markers (such as CEA, et al.) will be first collected within 7 days before surgery, and then be tested after radical gastrectomy in scheduled interval. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stomach adenocarcinoma patients who plan to receive radical gastrectomy and continuous circulating tumor DNA monitoring
Key inclusion criteria (8 listed)
- Male or female patients age 18 - 75.
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
- Histologically proven primary stomach adenocarcinoma with Lauren type by gastroscopic biopsy before operation.
- Clinical stage is cT3/4N+M0 and the tumor is resectable in initial evaluation.
- No preoperative tumor therapy, including chemotherapy, radiotherapy, et al.
Key exclusion criteria (5 listed)
- Radical gastrectomy was found cannot be achieved during operation due to metastasis or adjacent organ invasion.
- Only preoperative or postoperative blood sample was harvest or qualified.
- No qualified paired tissue samples.
- No complete clinicopatholoical information and follow-up.
- Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
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 |
|---|---|---|
| AVENIO ctDNA surveillance kitAVENIO circulating tumor DNA (ctDNA) Analysis Kits is a portfolio of three next-generation sequencing (NGS) liquid biopsy assay kits for oncology research: the AVENIO ctDNA Targeted Kit, Expanded Kit and Surveillance Kit. | Combination product | ctDNA detection |
Primary outcome
Description of disease recurrence risk according to first positive ctDNA detection
Time frame: 2 years
Time is measured from first positive ctDNA detection to disease-free survival event.
Description of ctDNA changing to adjuvant chemotherapy response
Time frame: 2 years
For subjects with postoperative positive ctDNA, time is measured from first adjuvant chemotherapy to first negative ctDNA detection.
2 secondary outcomes
Leading time between ctDNA detection and disease recurrence detected by conventional methods
Time frame: 2 years
The ctDNA level/mutations in gastric cancer preoperatively
Time frame: Within 7 days before operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
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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.
Zhaoqing Tang, MD principal investigator
Fudan University
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, run by Shanghai Zhongshan 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 8 inclusion and 5 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 27 Jun 2019. 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 Zhaoqing Tang, MD (86-21-64041990, tang.zhaoqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of disease recurrence risk according to first positive ctDNA detection (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 27 Jun 2019.