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Gastric NeoplasmsNCT03817866

Chromogranin A as Blood Marker in Cancer Patients

An observational study of Gastric Neoplasms and Pancreatic Neoplasms, run by Brahms AG at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
BRAHMS CgA II KRYPTOR
How many people
175 participants
Where
4 sitesin 2 countries
Study dates
29 Jan 2019to 14 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with diagnosed well-differentiated G1 and G2 GEP-NETs

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Stanford University Medical Center

    Palo Alto, California, 94305

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Germany1 site

  • Charité - Universitätsmedizin Berlin

    Berlin

Other trials in Germany

About this study

Official title: Chromogranin A as Surveillance Biomarker in Patients With cARcinoids (The CASPAR Study)

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.

Read the detailed description

A general characteristic for neuroendocrine tumors (NET) is expression of chromogranin A (CgA), which is released from neuroendocrine cells, occasionally together with cell specific hormones such as gastrin, insulin, somatostatin, and serotonin in functional tumors. Human CgA is an acidic 439 amino acid protein with a sequence containing several mono- and dibasic cleavage sites, and correspondingly, numerous fragments of CgA have been identified in tissue and plasma. CgA is critical to the formation of secretory granules that characterize NETs, and is therefore a useful marker for NETs.

Plasma concentrations of CgA and/or CgA fragments are elevated in most NETs. Moreover, since plasma CgA concentrations seem to be closely related to tumor burden in humans, plasma CgA concentration is an important prognostic factor. As such, high plasma concentrations of CgA as well as a dramatic increase in plasma CgA within a short time period, is associated with a poorer prognosis. Plasma CgA has also been suggested to be useful in the follow-up of patients with NETs.

Taken together, these observations support the notion that CgA is a promising biomarker candidate for monitoring treatment effectiveness and disease progression or regression.

Participation in this clinical study requires no additional visits to the oncologist, radiology or the laboratory. All information needed for the study will be obtained during typical visits as recommended by the oncologist. Clinical assessment of patients with GEP-NETs (according to NCCN guidelines) is based on physical exam, imaging (CT or MRI scans) and laboratory parameters. The course of disease is followed by RECIST 1.1 categorization including the evaluation of tumor burden by imaging.

Being tested
BRAHMS CgA II KRYPTOR
Keywords
Endocrine tumors, Carcinoids, Functional NETs, Non-functional NETs, Immunoassay
Medical subject headings
Stomach Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Carcinoid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BRAHMS CgA II KRYPTORDiagnostic test

    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).

Study groups in NCT03817866
Study groupRoleWhat they receive
BRAHMS CgA II KRYPTORAdult 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.
Receives: Diagnostic Test: BRAHMS CgA II KRYPTOR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Progression

    Progression vs. non-progression in patients with well-defined GEP-NETs assessed by RECIST 1.1 criteria

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2019
  2. Study start29 Jan 2019
  3. Primary completion14 Dec 2021
  4. Study completion14 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03817866
Sponsor's protocol ID
Brahms-CASPAR
Status last verified
Dec 2022
First submitted
24 Jan 2019
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19097774

  • Meng 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.

    PubMed 39453770

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Neoplasms and Pancreatic Neoplasms, run by Brahms AG at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Progression (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03817866, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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