Chromogranin A as Blood Marker in Cancer Patients

Not Recruiting

Trial ID: NCT03817866


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
Shagufta Shaheen

Clinical Assistant Professor, Medicine - Oncology

Run Zhang Shi

Clinical Associate Professor, Pathology


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


diagnostic_test: BRAHMS CgA II KRYPTOR

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathleen Hornbacker

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