Gastric NETNCT03812939
Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
An observational study of Gastric NET, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric NET
- What is being tested?
- Octreotide
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 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
- No healthy volunteers
- Adult, Older adult
Study population: Type I gastric NET patients from tertiary medical center
Who may be able to join
- Histologic diagnosis of gastric neuroendocrine tumor.
- Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body).
- Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status.
- No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy.
- SSA therapy is recommended by physician for disease management, and has not yet begun.
- Written informed consent obtained prior to treatment to be consistent with local regulatory requirements.
Who cannot join
- Pathological grading as G3 NET (Ki-67>20%).
- Patients with a known hypersensitivity to somatostatin analogs.
- Known gallbladder or bile duct disease, acute or chronic pancreatitis.
- Known medical condition related with prolonged QT interval.
- Pregnant or lactating women.
- Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
- Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
- Patients with a history of non-compliance to medical regimens.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jingnan Li, MD
About this study
Official title: An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.
- Conditions
- Gastric NET
- Being tested
- Octreotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Patients will receive 6-12 monthly injections every 28 (+/- 3) days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: 1 year
Secondary outcomes (4)
Change in clinical symptoms
Measured by a questionnaire, including whether the patient presents with dyspepsia, abdominal pain, cramps, bloating, nausea, vomiting, lack of appetite, facial flushing.
Measured: 6 months to 1 year
Concentration of serum Gastrin
Concentration of serum Gastrin after 12 hours of fasting
Measured: 6 months to 1 year
Enterochromaffin-like cell (ECL) status
Normal Hyperplasia: ECL cell proliferation with a diameter <150 μm, distinguished in: normal pattern/simple hyperplasia, linear, micronodular and adenomatoid hyperplasia.
Dysplasia: ECL cell proliferation >150 but <500 μm. Type I gastric carcinoid: ECL proliferation >500 μm.
Measured: 6 months to 1 year
Presence of side-effects of Octreotide
Measured by a questionnaire for patients and clinician's report. Including: hypersensitivity, endocrine disorders (abnormal thyroid functions), metabolism and nutrition disorders (abnormal blood glucose), headache, bradycardia or tachycardia, dyspnea, gastrointestinal disorders (diarrhea, abdominal pain, nausea, constipation, flatulence), hepatobiliary disorders, skin disorders, injection site reaction.
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric NETStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing-Nan Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812939
- Sponsor's protocol ID
- ZS-1788
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. No abstract available.
PubMed 26784901Merola E, Sbrozzi-Vanni A, Panzuto F, D'Ambra G, Di Giulio E, Pilozzi E, Capurso G, Lahner E, Bordi C, Annibale B, Delle Fave G. Type I gastric carcinoids: a prospective study on endoscopic management and recurrence rate. Neuroendocrinology. 2012;95(3):207-13. doi: 10.1159/000329043. Epub 2011 Jul 30.
PubMed 21811050Solcia E, Bordi C, Creutzfeldt W, Dayal Y, Dayan AD, Falkmer S, Grimelius L, Havu N. Histopathological classification of nonantral gastric endocrine growths in man. Digestion. 1988;41(4):185-200. doi: 10.1159/000199786.
PubMed 3072229
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
- ClinicalTrials.gov ID
- NCT03812939
- Acronym / sponsor ID
- ZS-1788
- Conditions
- Gastric NET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Jan 2019 (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.
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type I gastric NET patients from tertiary medical center
Key inclusion criteria (6 listed)
- Histologic diagnosis of gastric neuroendocrine tumor.
- Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body).
- Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status.
- No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy.
- SSA therapy is recommended by physician for disease management, and has not yet begun.
Key exclusion criteria (8 listed)
- Pathological grading as G3 NET (Ki-67>20%).
- Patients with a known hypersensitivity to somatostatin analogs.
- Known gallbladder or bile duct disease, acute or chronic pancreatitis.
- Known medical condition related with prolonged QT interval.
- Pregnant or lactating women.
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 |
|---|---|---|
| OctreotidePatients will receive 6-12 monthly injections every 28 (+/- 3) days. | Drug | – |
Primary outcome
Recurrence rate
Time frame: 1 year
4 secondary outcomes
Change in clinical symptoms
Time frame: 6 months to 1 year
Concentration of serum Gastrin
Time frame: 6 months to 1 year
Enterochromaffin-like cell (ECL) status
Time frame: 6 months to 1 year
Presence of side-effects of Octreotide
Time frame: 6 months to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 26784901Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. No abstract available.
- Background: PubMed 21811050Merola E, Sbrozzi-Vanni A, Panzuto F, D'Ambra G, Di Giulio E, Pilozzi E, Capurso G, Lahner E, Bordi C, Annibale B, Delle Fave G. Type I gastric carcinoids: a prospective study on endoscopic management and recurrence rate. Neuroendocrinology. 2012;95(3):207-13. doi: 10.1159/000329043. Epub 2011 Jul 30.
- Background: PubMed 3072229Solcia E, Bordi C, Creutzfeldt W, Dayal Y, Dayan AD, Falkmer S, Grimelius L, Havu N. Histopathological classification of nonantral gastric endocrine growths in man. Digestion. 1988;41(4):185-200. doi: 10.1159/000199786.
- Individual participant dataSharing planned: Undecided
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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.
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 NET, run by Peking Union Medical College 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 6 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 23 Jan 2019. 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 Chuyan Chen, MD (+86-17701095670, chuyanchen921@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 1 year). 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 NCT03812939, which also lists 3 linked publications.
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 23 Jan 2019.