Circulating Tumor CellsNCT03156777
Application Value of CTCs Detection for Advanced Gastric Cancer Patients
An observational study of Circulating Tumor Cells and Gastric Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Circulating Tumor Cells, Gastric Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2020
- How long will I take part?
- 3 Years
- 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: Advanced gastric cancer patients
Who may be able to join
- Subjects eligible for enrollment must meet all of the following criteria:
- Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures
- Men or women aged >= 18 years and <=75 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG) <= 2.
- Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction.
- Metastatic disease or locally advanced disease not amenable to curative surgery.
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- Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
- Life expectancy of at least 12 weeks with tumor and at least 5 years without tumor from the time of enrollment.
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
- No prior chemotherapy for advanced disease. -
Who cannot join
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Gastric carcinoid, sarcomas, or squamous cell cancer.
- Pregnant or lactating females.
- Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
- Active Hepatitis B or C or history of an HIV infection.
- Active uncontrolled infection. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Beiqing Jiang, +862125078922, xinhuakeyan@163.com
About this study
Official title: A Single Center Observational Study to Evaluate the Application Value of Circulating Tumor Cell Detection for Advanced Gastric Cancer Patients in Prediction of the Prognosis and Evaluation of the Outcome of Adjuvant Chemotherapy
Evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy.
- Conditions
- Circulating Tumor Cells, Gastric Cancer
- Keywords
- Gastric cancer; Circulating tumor cells; Prognosis
- Medical subject headings
- Neoplastic Cells, Circulating, Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating tumor cell (CTC)
Number of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy
Measured: Up to 2 years from start of study
Secondary outcomes (3)
Profile and Portion of circulating tumor cell (CTC)
Profile and Portion of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy. There are three type of CTCs: epithelial type CTC，mesenchymal type CTC and mixed type CTC. The portion of different type of CTC were calculated, for example: the portion of epithelia type CTC number to total CTCs,etc.
Measured: Up to 2 years from start of study
Progression-free survival
Survival duration since radical resection to clinical finding of relapse disease.
Measured: Up to 3 years from start of the study
Overall survival
Survival duration since radical resection to patient die.
Measured: Up to 5 years from start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellsStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Lu, M.D. & Ph.D., Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineYinbing Liu, M.D. & Ph.D., Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156777
- Sponsor's protocol ID
- XH-16-038
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2016
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Observational Study to Evaluate the Application Value of Circulating Tumor Cell Detection for Advanced Gastric Cancer Patients in Prediction of the Prognosis and Evaluation of the Outcome of Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03156777
- Acronym / sponsor ID
- XH-16-038
- Conditions
- Circulating Tumor Cells, Gastric Cancer
- Keywords
- Gastric cancer; Circulating tumor cells; Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 May 2017 (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.
Evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced gastric cancer patients
Key inclusion criteria (10 listed)
- Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures
- Men or women aged >= 18 years and <=75 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG) <= 2.
- Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction.
- Metastatic disease or locally advanced disease not amenable to curative surgery.
Key exclusion criteria (6 listed)
- Gastric carcinoid, sarcomas, or squamous cell cancer.
- Pregnant or lactating females.
- Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
- Active Hepatitis B or C or history of an HIV infection.
- Active uncontrolled infection. -
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
Number of circulating tumor cell (CTC)
Time frame: Up to 2 years from start of study
Number of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy
3 secondary outcomes
Profile and Portion of circulating tumor cell (CTC)
Time frame: Up to 2 years from start of study
Progression-free survival
Time frame: Up to 3 years from start of the study
Overall survival
Time frame: Up to 5 years from start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Wei Lu, M.D. & Ph.D. principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Yinbing Liu, M.D. & Ph.D. study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 Circulating Tumor Cells and Gastric Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 10 inclusion and 6 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 17 May 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?
Contact Xin Zhou, M.D. & Ph.D. (+862125078999, xinhuacru@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating tumor cell (CTC) (time frame: Up to 2 years from start of study). 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 17 May 2017.