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Chromogranin A as Blood Marker in Cancer Patients
Not Recruiting
Trial ID: NCT03817866
Purpose
Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are a heterogenous group of
neoplasms that arise from enterochromaffin cells of the gastrointestinal (GI) tract and
pancreas. They account for 50-70% of all incident NETs. Due to the lack of symptoms in the
early stage of disease and the frequency of nonspecific GI symptoms, GEP-NETs are difficult
to diagnose.
Identification of effective biomarkers (such as Chromogranin A) to improve GEP-NET diagnosis,
as well as to assess treatment efficacy, relapse and prognosis, is important for improving
outcomes for patients with GEP-NETs.
The purpose of this study is to validate the performance of Brahms (BRAHMS) Chromogranin A II
Kryptor (KRYPTOR) assay to monitor the course of disease in patients with well-defined
GEP-NETs.
Official Title
Chromogranin A as Surveillance Biomarker in Patients With cARcinoids (The CASPAR Study)
Stanford Investigator(s)
Shagufta Shaheen
Clinical Assistant Professor, Medicine - Oncology
Run Zhang Shi
Clinical Associate Professor, Pathology
Eligibility
Inclusion Criteria:
- Primary well-differentiated G1 and G2 neuroendocrine tumor located in jejunum, ileum,
colon, rectum, duodenum, appendix, stomach, or pancreas
- Measurable disease according to RECIST criteria (Version 1.1)
- Eighteen years of age or older
- CT or MRI order obtained and within 4 weeks of CgA measurement
- BRAHMS CgA II KRYPTOR baseline measurement available
- Patient has discontinued the following treatments for at least 3 weeks before study
start: i) proton pump Inhibitors (PPI), ii) corticoids, iii) H2-receptor antagonists
- Baseline Eastern Cooperative Oncology Group Performance Scale (ECOG PS) <2
- Written informed consent signed
Exclusion Criteria:
- Other active malignancy with the exclusion of melanoma or other cancers that occurred
more than 5 years ago
- Participation in another clinical trial involving an investigational therapeutic
(exception: diagnostic studies and studies evaluating known therapies)
- No measurable disease by RECIST criteria (Version 1.1)
- Severe renal dysfunction defined as creatinine of 1.5x upper limit of normal (ULN)
- Severe liver dysfunction in the absence of liver metastasis defined by aspartate
aminotransferase (AST), serum total bilirubin and/or alanine transaminase (ALT) 1.5x
ULN; severe liver dysfunction in the presence of liver metastasis defined by AST and
ALT over 5x ULN and total bilirubin over 1.5x ULN
- Severe gastrointestinal disorders (chronic atrophic gastritis, pancreatitis,
inflammatory bowel disease, irritable bowel syndrome)
- Severe cardiovascular disease (severe symptomatic congestive heart failure, pulmonary
artery hypertension, acute coronary syndrome)
- Patients receiving active treatment with the following medications and samples were
collected less than 3 weeks after discontinuing: i) proton pump Inhibitors (PPI), ii)
corticoids, iii) H2-receptor antagonists
- Chronic alcohol and/or substance abuse
- Known pregnancy
Intervention(s):
diagnostic test: BRAHMS CgA II KRYPTOR
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kathleen Hornbacker
650-721-4108