Status:
COMPLETED
Chromogranin A as Blood Marker in Cancer Patients
Lead Sponsor:
Brahms AG
Conditions:
Gastric Neoplasms
Pancreatic Neoplasms
Eligibility:
All Genders
18-85 years
Brief Summary
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 ...
Detailed Description
A general characteristic for neuroendocrine tumors (NET) is expression of chromogranin A (CgA), which is released from neuroendocrine cells, occasionally together with cell specific hormones such as g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03817866
Start Date
January 29 2019
End Date
December 14 2021
Last Update
December 20 2022
Active Locations (4)
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1
Stanford University Medical Center
Palo Alto, California, United States, 94305
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
Charité - Universitätsmedizin Berlin
Berlin, Germany