Early Gastric CancerNCT03632746
Verifying the Specificity of a New Method in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients
An observational study of Early Gastric Cancer and Lymph Node Metastases, run by Zhaode Bu, MD at 1 site in China.
Trial summary
Early gastric cancer is defined as gastric cancer that only invades mucosal or submucosal layer. The 5-year survival rate of gastric cancer can exceed 90% due to appropriate treatment. The most important consideration is whether there is lymph node metastasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Gastric Cancer, Lymph Node Metastases
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Dec 2020
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Early gastric cancer patients with clinical stage T1N0M0
Who may be able to join
- diagnosed as gastric cancer by gastroscopy
- pathologically confirmed as adenocarcinoma
- ages between 18 and 80
- gastroscopy, abdominal enhanced CT and EUS completed
- clinical stage T1N0M0
- the score of the Nomogram less than 110
- potential resectable gastric cancer
- signed informed consent
Who cannot join
- absolute indication for endoscopic submucosal dissection (ESD)
- tumor located in esophagogastric junction (EGJ)
- accepted adjuvant therap
- pregnant or breast feeding
- history of upper abdominal surgery (laparoscopic cholecystectomy not included)
- history of gastric surgery
- emergency surgery such as perforation or obstruction
- other contraindication such as dysfunction of heart, lung, kidney
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Yinan Zhang, M.D.
About this study
Official title: Verifying the Specificity of the Method Combining Nomogram and Sentinel Lymph Node in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients: a Prospective, Single Arm, Observational Study
Early gastric cancer is defined as gastric cancer that only invades mucosal or submucosal layer. The 5-year survival rate of gastric cancer can exceed 90% due to appropriate treatment. The most important consideration is whether there is lymph node metastasis. Preoperative examination including gastroscopy, endoscopic ultrasonography (EUS) and CT are not accurate enough to predict lymph node metastasis in early gastric cancer. In a retrospective study, we created a nomogram to predict lymph node metastasis in early gastric cancer. In prospective validation, the sensitivity and specificity of the nomogram was 75% and 91%, respectively. Sentinel lymph node is a promising concept in early gastric cancer. Using carbon nanoparticles as tracer, the sensitivity and specificity of sentinel lymph node predicting lymph node metastasis in early gastric cancer were 90% and 100%. Based on these results, we proposed a new method that combines the Nomogram and sentinel lymph node to predict lymph node metastasis in early gastric cancer. First, the probability of lymph node metastasis of early gastric cancer patients is calculated by the Nomogram. Those with low incidence of lymph node metastasis continue to the sentinel lymph node procedure. A patient will be considered non lymph node metastasis if his/her frozen pathology of the sentinel lymph nodes is negative during the surgery. Then the standard radical gastrectomy is performed with lymphadenectomy. By comparing postoperative pathology and sentinel lymph node frozen pathology, the specificity of Nomogram combining sentinel lymph node predicting lymph node metastasis in early gastric patients is calculated. The primary endpoint of this research is that the specificity of the above-mentioned method is over 95%.
- Conditions
- Early Gastric Cancer, Lymph Node Metastases
- Medical subject headings
- Stomach Neoplasms, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
The specificity of the Nomogram combining sentinel lymph node in predicting lymph node metastasis in early gastric cancer patients
Measured: 10 days after surgery when postoperative pathology result comes out
Secondary outcomes (2)
The sensitivity of the Nomogram combining sentinel lymph node in predicting lymph node metastasis in early gastric cancer patients
Measured: 10 days after surgery when postoperative pathology result comes out
The sensitivity of the Nomogram alone in predicting lymph node metastasis in early gastric cancer patients
Measured: 10 days after surgery when postoperative pathology result comes out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaode Bu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhaode Bu, MD, Peking University Cancer Hospital & Institute
- Investigators
- Zhaode Bu, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632746
- Sponsor's protocol ID
- Pre gastric preserving study
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verifying the Specificity of the Method Combining Nomogram and Sentinel Lymph Node in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients: a Prospective, Single Arm, Observational Study
- ClinicalTrials.gov ID
- NCT03632746
- Acronym / sponsor ID
- Pre gastric preserving study
- Conditions
- Early Gastric Cancer, Lymph Node Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhaode Bu, MDUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Aug 2018 (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.
Early gastric cancer is defined as gastric cancer that only invades mucosal or submucosal layer. The 5-year survival rate of gastric cancer can exceed 90% due to appropriate treatment. The most important consideration is whether there is lymph node metastasis. Preoperative examination including gastroscopy, endoscopic ultrasonography (EUS) and CT are not accurate enough to predict lymph node metastasis in early gastric cancer. In a retrospective study, we created a nomogram to predict lymph node metastasis in early gastric cancer. In prospective validation, the sensitivity and specificity of the nomogram was 75% and 91%, respectively. Sentinel lymph node is a promising concept in early gastric cancer. Using carbon nanoparticles as tracer, the sensitivity and specificity of sentinel lymph node predicting lymph node metastasis in early gastric cancer were 90% and 100%. Based on these results, we proposed a new method that combines the Nomogram and sentinel lymph node to predict lymph node metastasis in early gastric cancer. First, the probability of lymph node metastasis of early gastric cancer patients is calculated by the Nomogram. Those with low incidence of lymph node metastasis continue to the sentinel lymph node procedure. A patient will be considered non lymph node metastasis if his/her frozen pathology of the sentinel lymph nodes is negative during the surgery. Then the standard radical gastrectomy is performed with lymphadenectomy. By comparing postoperative pathology and sentinel lymph node frozen pathology, the specificity of Nomogram combining sentinel lymph node predicting lymph node metastasis in early gastric patients is calculated. The primary endpoint of this research is that the specificity of the above-mentioned method is over 95%.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Early gastric cancer patients with clinical stage T1N0M0
Key inclusion criteria (8 listed)
- diagnosed as gastric cancer by gastroscopy
- pathologically confirmed as adenocarcinoma
- ages between 18 and 80
- gastroscopy, abdominal enhanced CT and EUS completed
- clinical stage T1N0M0
Key exclusion criteria (8 listed)
- absolute indication for endoscopic submucosal dissection (ESD)
- tumor located in esophagogastric junction (EGJ)
- accepted adjuvant therap
- pregnant or breast feeding
- history of upper abdominal surgery (laparoscopic cholecystectomy not included)
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
The specificity of the Nomogram combining sentinel lymph node in predicting lymph node metastasis in early gastric cancer patients
Time frame: 10 days after surgery when postoperative pathology result comes out
2 secondary outcomes
The sensitivity of the Nomogram combining sentinel lymph node in predicting lymph node metastasis in early gastric cancer patients
Time frame: 10 days after surgery when postoperative pathology result comes out
The sensitivity of the Nomogram alone in predicting lymph node metastasis in early gastric cancer patients
Time frame: 10 days after surgery when postoperative pathology result comes out
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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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.
Zhaode Bu, M.D. principal investigator
Peking University Cancer Hospital & Institute
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 Early Gastric Cancer and Lymph Node Metastases, run by Zhaode Bu, MD 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 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 15 Aug 2018. 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 Yinan Zhang, M.D. (+86-18510115289, zhangyinan28@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specificity of the Nomogram combining sentinel lymph node in predicting lymph node metastasis in early gastric cancer patients (time frame: 10 days after surgery when postoperative pathology result comes out). 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 15 Aug 2018.