Clinical trial · Observational
Chromogranin A as Blood Marker in Cancer Patients
Chromogranin A as Surveillance Biomarker in Patients With cARcinoids (The CASPAR Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastric Neoplasms | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Small Intestinal Neoplasms | Small Intestinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BRAHMS CgA II KRYPTOR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- BRAHMS CgA II KRYPTOR
- description
- 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.
- interventionNames
- Diagnostic Test: BRAHMS CgA II KRYPTOR
Primary outcomes (1)
- measure
- Disease Progression
- timeFrame
- 36 months
- description
- Progression vs. non-progression in patients with well-defined GEP-NETs assessed by RECIST 1.1 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTEisenhauer 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 19097774
- DERIVEDMeng QH, Halfdanarson TR, Bornhorst JA, Jann H, Shaheen S, Shi RZ, Schwabe A, Stade K, Halperin DM. Circulating Chromogranin A as a Surveillance Biomarker in Patients with Carcinoids-The CASPAR Study. Clin Cancer Res. 2024 Dec 16;30(24):5559-5567. doi: 10.1158/1078-0432.CCR-24-1875. PMID 39453770