Chromogranin A as Blood Marker in Cancer Patients

Trial ID or NCT#

NCT03817866

Status

not recruiting iconNOT 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

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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)

Shagufta Shaheen
Shagufta Shaheen
Medical oncologist
Clinical Assistant Professor, Medicine - Oncology
Run Zhang Shi
Rheumatology/Immunology, Endocrinology, Immunodiagnosis pathologist
Clinical Associate Professor, Pathology

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Contact

Kathleen Hornbacker
650-721-4108