Gastric CancerNCT02610218
Liquid Biopsy in Monitoring the Therapeutic Efficacy of Targeted Therapy in Advanced/Metastatic Gastric Cancer
An observational study of Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- CTC and cfDNA analysis
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Anticipated 124 patients with histologically confirmed HER2 positive advanced/metastatic gastric cancer
Who may be able to join
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed HER2 positive gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Measurable disease according to the RECIST criteria
- Karnofsky performance status ≥60
Show all 13Show fewer
- Life expectancy of ≥2 month
- ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
- Serum albumin level ≥3.0g/dL
- Serum AKP < 2.5 times ULN
- Serum creatinine <ULN, and CCr < 60ml/min
- Bilirubin level < 1.5 ULN
- WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
Who cannot join
- Brain metastasis (known or suspected)
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry. Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
- Allergic constitution or allergic history to protium biologic product or any investigating agents.
- Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
- Pregnancy or lactation period
- Other previous malignancy within 5 year, except non-melanoma skin cancer
- Pre-existing neuropathy>grade 1
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
China1 site
Department of GI Oncology, Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer.
Read the detailed description
The study is a single-center, prospective study undertaken in anticipated 124 patients with both histologically HER2 positive and negative advanced/metastatic gastric cancer. Peripheral blood samples of 12.5 mL were collected from the patients for cfDNA and CTCs analysis. The blood samples will be respectively drawn before therapy, at the time that the patients achieve the optimal response and when they suffer progressive disease. The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. The correlation of the HER2 status on CTCs and the HER2 amplification in cfDNA to the therapeutic response will be evaluated. Moreover, gene variations associated with resistance in HER2-targeted therapy will be also studied based on the genomic data from sequencing of CTC and cfDNA.
- Conditions
- Gastric Cancer
- Being tested
- CTC and cfDNA analysis
- Keywords
- Cell free DNA, Circulating tumor cell, Therapeutic efficacy
- Medical subject headings
- Stomach Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC and cfDNA analysisOther
The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.
| Study group | Role | What they receive |
|---|---|---|
| histo-HER2+ gastric cancer patients | Histologically HER2 positive gastric cancer patients treated with HER2 targeted therapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease. Receives: Other: CTC and cfDNA analysis | |
| histo-HER2- gastric cancer patients | Histologically HER2 negative gastric cancer patients treated with chemotherapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease. Receives: Other: CTC and cfDNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of HER2 status on CTCs and cfDNA with clinical outcomes
To evaluate the correlation of CTCs and their HER2 expression status to the clinical outcomes
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Gene variations associated with resistance in HER2-targeted therapy
To study the gene variations associated with resistance in HER2-targeted therapy based on the genomic data from sequencing of CTC and cfDNA
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startApr 2016
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (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 Peking UniversityThe 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610218
- Sponsor's protocol ID
- LiquidBiopsy
- Status last verified
- Oct 2017
- First submitted
- 18 Nov 2015
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy in Monitoring the Therapeutic Efficacy of Targeted Therapy in Advanced/Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT02610218
- Acronym / sponsor ID
- LiquidBiopsy
- Conditions
- Gastric Cancer
- Keywords
- Cell free DNA, Circulating tumor cell, Therapeutic efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- 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.
To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer.
Detailed description
The study is a single-center, prospective study undertaken in anticipated 124 patients with both histologically HER2 positive and negative advanced/metastatic gastric cancer. Peripheral blood samples of 12.5 mL were collected from the patients for cfDNA and CTCs analysis. The blood samples will be respectively drawn before therapy, at the time that the patients achieve the optimal response and when they suffer progressive disease. The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. The correlation of the HER2 status on CTCs and the HER2 amplification in cfDNA to the therapeutic response will be evaluated. Moreover, gene variations associated with resistance in HER2-targeted therapy will be also studied based on the genomic data from sequencing of CTC and cfDNA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| histo-HER2+ gastric cancer patients | – | Other: CTC and cfDNA analysisHistologically HER2 positive gastric cancer patients treated with HER2 targeted therapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease. |
| histo-HER2- gastric cancer patients | – | Other: CTC and cfDNA analysisHistologically HER2 negative gastric cancer patients treated with chemotherapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anticipated 124 patients with histologically confirmed HER2 positive advanced/metastatic gastric cancer
Key inclusion criteria (13 listed)
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed HER2 positive gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Measurable disease according to the RECIST criteria
Key exclusion criteria (8 listed)
- Brain metastasis (known or suspected)
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry. Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
- Allergic constitution or allergic history to protium biologic product or any investigating agents.
- Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
- Pregnancy or lactation period
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 |
|---|---|---|
| CTC and cfDNA analysisThe enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol. | Other | histo-HER2+ gastric cancer patients, histo-HER2- gastric cancer patients |
Primary outcome
Correlation of HER2 status on CTCs and cfDNA with clinical outcomes
Time frame: through study completion, an average of 1 year
To evaluate the correlation of CTCs and their HER2 expression status to the clinical outcomes
1 secondary outcome
Gene variations associated with resistance in HER2-targeted therapy
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Peking University 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 13 inclusion and 8 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 31 Oct 2017. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of HER2 status on CTCs and cfDNA with clinical outcomes (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 31 Oct 2017.