Chromogranin A as Blood Marker in Cancer Patients
Trial ID or NCT#
Status
NOT RECRUITING
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)
Eligibility 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
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Kathleen Hornbacker
650-721-4108
View on