Chromogranin A as Blood Marker in Cancer Patients
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- diagnostic test: BRAHMS CgA II KRYPTOR
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
Ages Eligible for Study
18 Years - 85 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kathleen Hornbacker
650-721-4108
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.