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Chromogranin A as Blood Marker in Cancer Patients

NCT03817866 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2022-12-20

No results posted yet for this study

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.

Conditions

  • Gastric Neoplasms
  • Pancreatic Neoplasms
  • Small Intestinal Neoplasms
  • Colorectal Neoplasms

Interventions

DIAGNOSTIC_TEST

BRAHMS CgA II KRYPTOR

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).

Sponsors & Collaborators

  • Brahms AG

    lead INDUSTRY

Principal Investigators

  • Daniel M Halperin, MD · The University of Texas MD Anderson Cancer Center

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03817866 on ClinicalTrials.gov