Study Using Chromogranin A as Surveillance Biomarker in Patients with cARcinoids
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-007808
NCT ID: NCT03817866
Sponsor Protocol Number: 18-007808
About this study
The purpose of this study is to monitor and validate the performance and stability of the BRAHMS Chromogranin A (CgA) II KRYPTOR Assay in patients with Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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).
- 18 years of age or older.
- CT or MRI order obtained and within 4 weeks of CgA measurement.
- B·R·A·H·M·S CgA II KRYPTOR baseline measurement available.
- Patient has discontinued the following treatments for a least 3 weeks before study start:
- Proton pump inhibitors (PPI);
- Corticoids;
- H2-receptor antagonists.
- Baseline 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 1.5 x ULN.
- Severe liver dysfunction in the absence of liver metastasis defined by aspartate aminotransferase (AST), serum total bilirubin and/or alanine transaminase (ALT) 1.5 x ULN; Severe liver dysfunction in the presence of liver metastasis defined by AST and ALT over 5 x ULN and total bilirubin over 1.5 x 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:
- Proton pump inhibitors (PPI);
- Corticoids;
- H2-receptor antagonists.
- Chronic alcohol and/or substance abuse.
- Known pregnancy.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available