Chromogranin A as Blood Marker in Cancer Patients
Chromogranin A as Surveillance Biomarker in Patients With cARcinoids (The CASPAR Study)
1 other identifier
observational
175
2 countries
4
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedStudy Start
First participant enrolled
January 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2021
CompletedDecember 20, 2022
December 1, 2022
2.9 years
January 24, 2019
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Progression
Progression vs. non-progression in patients with well-defined GEP-NETs assessed by RECIST 1.1 criteria
36 months
Study Arms (1)
BRAHMS CgA II KRYPTOR
Adult patients with well defined grade 1 and grade 2 GEP-NETs. Serial serum samples from all patients will be analyzed using the BRAHMS CgA II KRYPTOR Assay.
Interventions
The BRAHMS CgA II KRYPTOR kit is an automated immunofluorescent assay for the quantitative determination of the concentration of CgA in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with GEP-NETs (grade 1 and grade 2). Serial testing for patient BRAHMS CgA II KRYPTOR assay values should be used in conjunction with other clinical methods for monitoring GEP-NETs (grade 1 and grade 2).
Eligibility Criteria
Adult patients with diagnosed well-differentiated G1 and G2 GEP-NETs
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brahms AGlead
Study Sites (4)
Stanford University Medical Center
Palo Alto, California, 94305, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Charité - Universitätsmedizin Berlin
Berlin, Germany
Related Publications (1)
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PMID: 19097774RESULT
Related Links
Biospecimen
Serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel M Halperin, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2019
First Posted
January 28, 2019
Study Start
January 29, 2019
Primary Completion
December 14, 2021
Study Completion
December 14, 2021
Last Updated
December 20, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share