Gastritis, AtrophicSBSDSNCT02915393
System Biology of Spleen Deficiency Syndrome
An observational study of Gastritis, Atrophic and Gastric Cancer, run by Beijing University of Chinese Medicine.
Trial summary
Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastritis, Atrophic, Gastric Cancer
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 90 cases will be gathered between August, 2016 and September, 2017. All the cases include: ①10 healthy volunteers in Beijing with balanced constitution, 10 with Qi Deficient Constitution (Spleen-qi Deficiency Syndrome) and 10 with Damp-heat Constitution. ②Patients in Dongfang Hospital diagnosed as chronic superficial gastritis,chronic atrophic gastritis or gastric cancer, 20 for each disease and half of each with Spleen-qi Deficiency Syndrome, half with Spleen Damp-heat Syndrome.
Who may be able to join
- Aged between 18 and 65 years.
- No apparent abnormality in the routine blood test, urinalysis, routine stool \& fecal occult blood test, biochemical test, chest radiograph and electrocardiogram(ECG).
- The endoscopic diagnoses of chronic superficial gastritis, chronic atrophic gastritis and gastric cancer conform to the corresponding pathological diagnoses
- TCM diagnoses of Spleen-qi Deficiency Syndrome or Spleen Damp-heat Syndrome.
- Voluntary participation.
- Having given written informed consent.
Who cannot join
- Gastropathy with special causes, such as acute gastritis, gastrinoma, chronic gastritis resulting from special causes (like granulomatous gastritis, lymphocytic gastritis, eosinophilic gastritis, gastritis after gastric operation) peptic ulcer, other malignant tumors of stomach (like gastric lymphoma, gastri stromal tumor, carcinoid tumor, malignant hemangioma, squamous-cell carcinoma, primary gastric choriocarcinoma and metastatic gastric tumor), benign gastritic tumors that originate from epithelium or submucosa (epithelial tumors like adenomatous polyps and hyperplastic polyps, stromal tumors like benign stromal tumor, neuronal tumor and pseudolymphoma).
- Combined with other digestive diseases (like gastroesophageal reflux, esophageal varices, acute and chronic hepatitis and cirrhosis arising from various causes, acute/chronic pancreatitis and acute/chronic cholecystitis).
- Combined with other severe systemic diseases such as respiratory failure, severe cardiovascular and cerebrovascular, immune system, urinary and mental disorders diseases.
- Pregnancy, or planning pregnancy during the trial or within three month period thereafter.
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
Trial locations and contacts
No sites are listed yet.
Leiming You contact
About this study
Official title: System Biology Research of Spleen Qi Deficiency Associated "Qi Deficiency Constitution-Disease"
Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be included, and the corresponding research would be conducted at the molecular-cell-gastric tissue level, and at the same time, systematical biological database of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing technology created in our research group, proteomics and metabonomics. Under the above work, the investigators would conduct data mining and molecular network analysis, and then verify the key functions. By analyzing the systematical biological features of syndrome and its relationships with constitution and disease, this study would provide a new basis for objective reality of syndrome, and also offer a crucial premise of revealing biological basis for syndrome correctly, which is of important theoretical and practical significance.
- Conditions
- Gastritis, Atrophic, Gastric Cancer
- Keywords
- Chronic Gastritis, Qi Deficiency Constitution, Next Generation Sequencing, Proteomics, Metabonomics
- Medical subject headings
- Gastritis, Atrophic, Stomach Neoplasms
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 |
|---|---|---|
| Healthy Volunteers (BC) | Healthy Volunteers with Balanced Constitution(n=10). | |
| Healthy Volunteers(QC) | Healthy Volunteers with Qi Deficiency Constitution(n=10). | |
| Healthy Volunteers(DC) | Healthy Volunteers with Damp-heat Constitution(n=10). | |
| Superficial Gastritis(SDS) | Superficial Gastritis with Spleen-qi Deficiency Syndrome(n=10). | |
| Superficial Gastritis(DS) | Superficial Gastritis with Damp-heat Syndrome(n=10). | |
| Atrophic Gastritis(SDS) | Atrophic Gastritis with Spleen-qi Deficiency Syndrome(n=10). | |
| Atrophic Gastritis(DS) | Atrophic Gastritis with Damp-heat Syndrome(n=10). | |
| Gastric Cancer(SDS) | Gastric Cancer with Spleen-qi Deficiency Syndrome(n=10). | |
| Gastric Cancer(DS) | Gastric Cancer with Damp-heat Syndrome(n=10). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of the stomach with an endoscope.
Endoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.
Measured: at the beginning of the enrollment
Pathological biopsy of gastric mucosa.
Pathological diagnosis standard of chronic gastritis according to Chinese Society of Gastroenterology.Pathological diagnosis standard of gastric cancer according to Ministry of Health P.R.China
Measured: at the beginning of the enrollment
Detection of helicobacter pylori by Urea Breath Test(UBT)
Measured: at the beginning of the enrollment
Secondary outcomes (3)
Analysis of gastric mucosa/venous blood/urine by system biology techniques
Measured: Three measurements within 1 year
Constitutional classification of TCM assessed by the Traditional Chinese Medicine Physical Constitution Scale
Measured: at the beginning of the enrollment
TCM syndrome type diagnosed by two professional TCM doctors
Measured: at the beginning of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionDec 2019 (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 Gastritis, AtrophicStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anlong Xu, Beijing University of Chinese Medicine
- Investigators
- Anlong Xu, Principal investigator, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915393
- Sponsor's protocol ID
- 81430099
- Acronym
- SBSDS
- Status last verified
- Sep 2016
- First submitted
- 17 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
You L, Zhang S, Li T, Sang X, Li K, Wang W, Gao X, Wu J, Huang G, Wang T, Xu A. Integrated analyses of miRNA and mRNA profiles in leukocytes and serums in traditional Chinese medicine (TCM)-defined Pi-qi-deficiency syndrome and Pi-wei damp-heat syndrome resulting from chronic atrophic gastritis. Chin Med. 2021 Jan 6;16(1):4. doi: 10.1186/s13020-020-00416-9.
PubMed 33407671
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System Biology Research of Spleen Qi Deficiency Associated "Qi Deficiency Constitution-Disease"
- ClinicalTrials.gov ID
- NCT02915393
- Acronym / sponsor ID
- SBSDS / 81430099
- Conditions
- Gastritis, Atrophic, Gastric Cancer
- Keywords
- Chronic Gastritis, Qi Deficiency Constitution, Next Generation Sequencing, Proteomics, Metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Sep 2016 (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.
Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be included, and the corresponding research would be conducted at the molecular-cell-gastric tissue level, and at the same time, systematical biological database of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing technology created in our research group, proteomics and metabonomics. Under the above work, the investigators would conduct data mining and molecular network analysis, and then verify the key functions. By analyzing the systematical biological features of syndrome and its relationships with constitution and disease, this study would provide a new basis for objective reality of syndrome, and also offer a crucial premise of revealing biological basis for syndrome correctly, which is of important theoretical and practical significance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers (BC) | – | –Healthy Volunteers with Balanced Constitution(n=10). |
| Healthy Volunteers(QC) | – | –Healthy Volunteers with Qi Deficiency Constitution(n=10). |
| Healthy Volunteers(DC) | – | –Healthy Volunteers with Damp-heat Constitution(n=10). |
| Superficial Gastritis(SDS) | – | –Superficial Gastritis with Spleen-qi Deficiency Syndrome(n=10). |
| Superficial Gastritis(DS) | – | –Superficial Gastritis with Damp-heat Syndrome(n=10). |
| Atrophic Gastritis(SDS) | – | –Atrophic Gastritis with Spleen-qi Deficiency Syndrome(n=10). |
| Atrophic Gastritis(DS) | – | –Atrophic Gastritis with Damp-heat Syndrome(n=10). |
| Gastric Cancer(SDS) | – | –Gastric Cancer with Spleen-qi Deficiency Syndrome(n=10). |
| Gastric Cancer(DS) | – | –Gastric Cancer with Damp-heat Syndrome(n=10). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 90 cases will be gathered between August, 2016 and September, 2017. All the cases include: ①10 healthy volunteers in Beijing with balanced constitution, 10 with Qi Deficient Constitution (Spleen-qi Deficiency Syndrome) and 10 with Damp-heat Constitution. ②Patients in Dongfang Hospital diagnosed as chronic superficial gastritis,chronic atrophic gastritis or gastric cancer, 20 for each disease and half of each with Spleen-qi Deficiency Syndrome, half with Spleen Damp-heat Syndrome.
Key inclusion criteria (6 listed)
- Aged between 18 and 65 years.
- No apparent abnormality in the routine blood test, urinalysis, routine stool \& fecal occult blood test, biochemical test, chest radiograph and electrocardiogram(ECG).
- The endoscopic diagnoses of chronic superficial gastritis, chronic atrophic gastritis and gastric cancer conform to the corresponding pathological diagnoses
- TCM diagnoses of Spleen-qi Deficiency Syndrome or Spleen Damp-heat Syndrome.
- Voluntary participation.
Key exclusion criteria (5 listed)
- Gastropathy with special causes, such as acute gastritis, gastrinoma, chronic gastritis resulting from special causes (like granulomatous gastritis, lymphocytic gastritis, eosinophilic gastritis, gastritis after gastric operation) peptic ulcer, other malignant tumors of stomach (like gastric lymphoma, gastri stromal tumor, carcinoid tumor, malignant hemangioma, squamous-cell carcinoma, primary gastric choriocarcinoma and metastatic gastric tumor), benign gastritic tumors that originate from epithelium or submucosa (epithelial tumors like adenomatous polyps and hyperplastic polyps, stromal tumors like benign stromal tumor, neuronal tumor and pseudolymphoma).
- Combined with other digestive diseases (like gastroesophageal reflux, esophageal varices, acute and chronic hepatitis and cirrhosis arising from various causes, acute/chronic pancreatitis and acute/chronic cholecystitis).
- Combined with other severe systemic diseases such as respiratory failure, severe cardiovascular and cerebrovascular, immune system, urinary and mental disorders diseases.
- Pregnancy, or planning pregnancy during the trial or within three month period thereafter.
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
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
Examination of the stomach with an endoscope.
Time frame: at the beginning of the enrollment
Endoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.
Pathological biopsy of gastric mucosa.
Time frame: at the beginning of the enrollment
Pathological diagnosis standard of chronic gastritis according to Chinese Society of Gastroenterology.Pathological diagnosis standard of gastric cancer according to Ministry of Health P.R.China
Detection of helicobacter pylori by Urea Breath Test(UBT)
Time frame: at the beginning of the enrollment
3 secondary outcomes
Analysis of gastric mucosa/venous blood/urine by system biology techniques
Time frame: Three measurements within 1 year
Constitutional classification of TCM assessed by the Traditional Chinese Medicine Physical Constitution Scale
Time frame: at the beginning of the enrollment
TCM syndrome type diagnosed by two professional TCM doctors
Time frame: at the beginning of the enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 33407671You L, Zhang S, Li T, Sang X, Li K, Wang W, Gao X, Wu J, Huang G, Wang T, Xu A. Integrated analyses of miRNA and mRNA profiles in leukocytes and serums in traditional Chinese medicine (TCM)-defined Pi-qi-deficiency syndrome and Pi-wei damp-heat syndrome resulting from chronic atrophic gastritis. Chin Med. 2021 Jan 6;16(1):4. doi: 10.1186/s13020-020-00416-9.
- Individual participant dataSharing planned: Undecided
Related trials for Gastritis, Atrophic
RecruitingObservational study
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Helicobacter Pylori, Atrophic Gastritis
RecruitingObservational study
Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis
Gastric Cancer, Intestinal Metaplasia
Active, not recruitingPhase 2
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
Chronic Atrophic Gastritis, Gastric Carcinoma
Enrolling by invitationObservational study
UC Davis Cohort of Pre-Malignant and Malignant Gastro-Intestinal DisEases Study
Intestinal Metaplasia, Chronic Gastritis
RecruitingObservational study
The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies
Functional Dyspepsia, Gastritis
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.
Leiming You contact
Anlong Xu principal investigator
Beijing University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Gastritis, Atrophic and Gastric Cancer, run by Beijing University of Chinese Medicine.
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 5 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaopu Sang (+86 15101021386, sxp@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination of the stomach with an endoscope. (time frame: at the beginning of the enrollment). The study lists 3 primary outcomes in all. 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 NCT02915393, 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 27 Sep 2016.