Study Using Chromogranin A as Surveillance Biomarker in Patients with cARcinoids

Overview

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thorvardur Halfdanarson, M.D.

Open for enrollment

Contact information:

Julie Faust R.N.

(507)266-3242

Faust.Julie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20447457

Mayo Clinic Footer