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Trial record 8 of 40 for:    somatostatin analogues | Neuroendocrine Tumors

Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs

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ClinicalTrials.gov Identifier: NCT03812939
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jing-Nan Li, Peking Union Medical College Hospital

Brief Summary:
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.

Condition or disease Intervention/treatment
Gastric NET Drug: Octreotide

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Octreotide
    Patients will receive 6-12 monthly injections every 28 (+/- 3) days.


Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Change in clinical symptoms [ Time Frame: 6 months to 1 year ]
    Measured by a questionnaire, including whether the patient presents with dyspepsia, abdominal pain, cramps, bloating, nausea, vomiting, lack of appetite, facial flushing.

  2. Concentration of serum Gastrin [ Time Frame: 6 months to 1 year ]
    Concentration of serum Gastrin after 12 hours of fasting

  3. Enterochromaffin-like cell (ECL) status [ Time Frame: 6 months to 1 year ]

    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.


  4. Presence of side-effects of Octreotide [ Time Frame: 6 months to 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type I gastric NET patients from tertiary medical center
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812939


Contacts
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Contact: Chuyan Chen, MD +86-17701095670 chuyanchen921@126.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Jingnan Li, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital

Publications:
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Responsible Party: Jing-Nan Li, Head of Gastroenterology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03812939     History of Changes
Other Study ID Numbers: ZS-1788
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Somatostatin
Recurrence
Disease Attributes
Pathologic Processes
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs