Gastric CancerNCT01848015
Circulating Tumor Cells (CTCs) in Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced gastric cancer after radical resection. To identify the relationship between the detection of circulation tumor cells and recurrence patterns of gastric cancer after radical resection. 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?
- detection of CTCs
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2016
- 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: The patients with advanced gastric cancer accepted radical resection(D2)
Who may be able to join
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- Preoperative clinical examination and imaging indicating operable disease
- complete resection (R0 resection)
- D2 or D2+ resection
Who cannot join
- Other tumor type than adenocarcinoma
- Patients who have been given preoperative chemotherapy/chemoradiation.
- Staging investigations or intraoperative exploration indicating inoperable disease
- R1 or R2 resection
- D0 or D1 resection
- Patients unreliable for follow up
- Past history of malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking cancer hospital
Beijing, Beijing Municipality, 100142
Ming Lu, MD, (86)10-88196561, qiminglu_mail@126.com
About this study
Official title: Prediction of Recurrence in Advanced Gastric Cancer After Radical Resection by Circulating Tumor Cells （CTCs）
To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced gastric cancer after radical resection.
To identify the relationship between the detection of circulation tumor cells and recurrence patterns of gastric cancer after radical resection.
- Conditions
- Gastric Cancer
- Being tested
- detection of CTCs
- Keywords
- CTCs before and after gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of CTCsOther
| Study group | Role | What they receive |
|---|---|---|
| CTCs positive | Not described Receives: Other: detection of CTCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTCs
Measured: 2 months
Secondary outcomes (1)
Recurrence of gastric cancer after radical resection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848015
- Sponsor's protocol ID
- CGOG5003
- Status last verified
- May 2015
- First submitted
- 3 May 2013
- Last updated
- 19 May 2015
- Results posted
- No
Publications
Zhang Q, Shan F, Li Z, Gao J, Li Y, Shen L, Ji J, Lu M. A prospective study on the changes and clinical significance of pre-operative and post-operative circulating tumor cells in resectable gastric cancer. J Transl Med. 2018 Jun 20;16(1):171. doi: 10.1186/s12967-018-1544-1.
PubMed 29925382
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recurrence in Advanced Gastric Cancer After Radical Resection by Circulating Tumor Cells （CTCs）
- ClinicalTrials.gov ID
- NCT01848015
- Acronym / sponsor ID
- CGOG5003
- Conditions
- Gastric Cancer
- Keywords
- CTCs before and after gastrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 7 May 2013 (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 assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced gastric cancer after radical resection.
To identify the relationship between the detection of circulation tumor cells and recurrence patterns of gastric cancer after radical resection.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTCs positive | – | Other: detection of CTCs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with advanced gastric cancer accepted radical resection(D2)
Key inclusion criteria (6 listed)
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- Preoperative clinical examination and imaging indicating operable disease
- complete resection (R0 resection)
Key exclusion criteria (7 listed)
- Other tumor type than adenocarcinoma
- Patients who have been given preoperative chemotherapy/chemoradiation.
- Staging investigations or intraoperative exploration indicating inoperable disease
- R1 or R2 resection
- D0 or D1 resection
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 |
|---|---|---|
| detection of CTCs | Other | CTCs positive |
Primary outcome
CTCs
Time frame: 2 months
1 secondary outcome
Recurrence of gastric cancer after radical resection
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Derived from this study: PubMed 29925382Zhang Q, Shan F, Li Z, Gao J, Li Y, Shen L, Ji J, Lu M. A prospective study on the changes and clinical significance of pre-operative and post-operative circulating tumor cells in resectable gastric cancer. J Transl Med. 2018 Jun 20;16(1):171. doi: 10.1186/s12967-018-1544-1.
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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.
Lin Shen, MD, PhD principal investigator
Peking 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 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 6 inclusion and 7 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 19 May 2015. 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 Lin Shen, MD,PhD ((86)10-88196175, lin100@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTCs (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848015, which also lists 1 linked publication.
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 19 May 2015.