Lymph Node MetastasesNCT03478449
The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer
A study testing lymph node sorting for pathological examination in people with Lymph Node Metastases and Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymph Node Metastases, Gastric Cancer, Exanimation
- What is being tested?
- lymph node sorting for pathological examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 Dec 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Physical conditions compliance with the requirements for curative gastrectomy
- 2) Consent to undergo the D2 lymphadenectomy
- 3) Comply with the protocol during the whole study period
- 4) No neoadjuvant therapy administration
- 5) Sign informed consent and permission of withdraw in the whole study period
- 6) Consent to provide the tissue specimens after surgery for this study
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- 7) Pathological examination confirmation the adenocarcinoma of stomach before surgery
- 8) Estimation the overall survival after surgery no less than 6 months
- 9) No anesthesia or operation contraindication disease
- 10) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
- 11) Negative cytological detection in operation
- 12) No seriously concomitance's diseases
- 13) Karnofsky Performance Scores (KPS) more than 60
Who cannot join
- 1) Women during pregnant stage and breast-feed stage
- 2) Women of childbearing age without any contraceptive measures
- 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- 4) Immunosuppressive therapists for organ transplantation
- 5) Seriously uncontrolled recurrent infection
- 6) other malignant tumors
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- 7) No abilities of self-knowledge or mental disorders
- 8) Participating in other clinical trials
- 9) Siewert I and II esophagogastric junction tumors
- 10) Serious internal diseases obstruction surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer
The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.
- Conditions
- Lymph Node Metastases, Gastric Cancer, Exanimation
- Being tested
- lymph node sorting for pathological examination
- Medical subject headings
- Lymphatic Metastasis, Stomach Neoplasms, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph node sorting for pathological examinationProcedure or surgery
In this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis.
| Study group | Role | What they receive |
|---|---|---|
| Fine sorting lymph node group | Experimental | Not described Receives: Procedure: lymph node sorting for pathological examination |
| Regional sorting lymph node group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of pN stage in gastric cancer patients
According to the overall survival of all included patients, we will evaluate the optimal lymph node sorting method to obtain the accurately pathological stage of lymph node metastatic counts (pN stage) for prediction the prognosis of patients after curative surgery for gastric cancer.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Apr 2018
- Primary completion2 Nov 2020
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node MetastasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478449
- Sponsor's protocol ID
- DJY001
- Status last verified
- Nov 2020
- First submitted
- 10 Feb 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer
- ClinicalTrials.gov ID
- NCT03478449
- Acronym / sponsor ID
- DJY001
- Conditions
- Lymph Node Metastases, Gastric Cancer, Exanimation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 27 Mar 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.
The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fine sorting lymph node group | Experimental | Procedure: lymph node sorting for pathological examination |
| Regional sorting lymph node group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1) Physical conditions compliance with the requirements for curative gastrectomy
- 2) Consent to undergo the D2 lymphadenectomy
- 3) Comply with the protocol during the whole study period
- 4) No neoadjuvant therapy administration
- 5) Sign informed consent and permission of withdraw in the whole study period
Key exclusion criteria (10 listed)
- 1) Women during pregnant stage and breast-feed stage
- 2) Women of childbearing age without any contraceptive measures
- 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- 4) Immunosuppressive therapists for organ transplantation
- 5) Seriously uncontrolled recurrent infection
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 |
|---|---|---|
| lymph node sorting for pathological examinationIn this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis. | Procedure or surgery | Fine sorting lymph node group |
Primary outcome
Migration of pN stage in gastric cancer patients
Time frame: 60 months
According to the overall survival of all included patients, we will evaluate the optimal lymph node sorting method to obtain the accurately pathological stage of lymph node metastatic counts (pN stage) for prediction the prognosis of patients after curative surgery for gastric cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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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?
A study testing lymph node sorting for pathological examination in people with Lymph Node Metastases and Gastric Cancer, run by Tianjin Medical University Cancer Institute and 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 13 inclusion and 10 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 13 Nov 2020. 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?
Migration of pN stage in gastric cancer patients (time frame: 60 months). 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 13 Nov 2020.