Gastric CancerNCT03493880
The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments
An observational study of Gastric Cancer and Neoadjuvant Chemotherapy, run by Peking University at 1 site in China.
Trial summary
Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2015to 1 Sep 2025
- How long will I take part?
- 5 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients with advanced gastric cancer or esophagogastric cancer receiving neoadjuvant chemotherapy or chemoradiotherapy will be included for this observational study.
Who may be able to join
- Histologically confirmed adenocarcinoma
- Received neoadjuvant (preoperative) chemotherapy or chemoradiotherapy
- Diagnosed clinical advanced gastric cancer or esophagogastric cancer
Who cannot join
- Lack of immuno-nutrition data
Trial locations and contacts
1 site in 1 country.
Shuangxi Li, M.D., Ph.D. contact
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Shuangxi Li, M.D., lishx@hsc.pku.edu.cn
Jiafu Ji, M.D.,Ph.D.
About this study
Official title: The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments: Observational Cohort Study
Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.
Read the detailed description
The immune (systemic inflammation) index includes:
NLR (Neutrophil-to-Lymphocyte Ratio); PLR (Platelet-to-Lymphocyte Ratio); SII (Systemic Immune-Inflammation Index); GPS (Glasgow Prognostic Score); mGPS (modified Glasgow Prognostic Score); PI (Prognostic Index);
The nutrition index includes:
NRS2002; PNI (Prognostic Nutrition Index);
- Conditions
- Gastric Cancer, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy, Systemic Inflammatory Response Syndrome (SIRS), Nutrition Aspect of Cancer
- Medical subject headings
- Stomach Neoplasms, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| naCT | Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemotherapy. | |
| naCRT | Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemoradiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response
Pathological response
Measured: One month after surgery
Secondary outcomes (4)
3-years overall survival
3-years overall survival
Measured: Three years after surgery
3-years disease-free survival
3-years disease-free survival
Measured: Three years after surgery
Postoperative morbidity
Postoperative morbidity
Measured: One month after surgery
yp TNM Stage
yp TNM Stage
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Sep 2015
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2025 (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
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuang-xi Li, Peking University
- Investigators
- Jiafu Ji, M.D., Ph.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493880
- Sponsor's protocol ID
- INdex
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments: Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03493880
- Acronym / sponsor ID
- INdex
- Conditions
- Gastric Cancer, Neoadjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy, Systemic Inflammatory Response Syndrome (SIRS), Nutrition Aspect of Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 11 Apr 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.
Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.
Detailed description
The immune (systemic inflammation) index includes:
NLR (Neutrophil-to-Lymphocyte Ratio); PLR (Platelet-to-Lymphocyte Ratio); SII (Systemic Immune-Inflammation Index); GPS (Glasgow Prognostic Score); mGPS (modified Glasgow Prognostic Score); PI (Prognostic Index);
The nutrition index includes:
NRS2002; PNI (Prognostic Nutrition Index);
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naCT | – | –Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemotherapy. |
| naCRT | – | –Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemoradiotherapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients with advanced gastric cancer or esophagogastric cancer receiving neoadjuvant chemotherapy or chemoradiotherapy will be included for this observational study.
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma
- Received neoadjuvant (preoperative) chemotherapy or chemoradiotherapy
- Diagnosed clinical advanced gastric cancer or esophagogastric cancer
Key exclusion criteria (1 listed)
- Lack of immuno-nutrition data
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
Pathological response
Time frame: One month after surgery
Pathological response
4 secondary outcomes
3-years overall survival
Time frame: Three years after surgery
3-years disease-free survival
Time frame: Three years after surgery
Postoperative morbidity
Time frame: One month after surgery
yp TNM Stage
Time frame: One month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
Shuangxi Li, M.D., Ph.D. contact
Jiafu Ji, M.D., Ph.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 Gastric Cancer and Neoadjuvant Chemotherapy, 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 3 inclusion and 1 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 11 Apr 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 Shuangxi Li, M.D., Ph.D. (lishx@hsc.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response (time frame: One month after surgery). 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 11 Apr 2018.