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

New Trial Alerts

Receive email alerts when trials open to patients.