Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT03817866
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03817866
Study Brief:
Protocol Section:
NCT03817866