Early Release of Chromogranin A (CgA)NCT06183047
Predictive Value of Early Changes of Chromogranin A Levels in Patients With Neuroendocrine Tumours Treated With PRRT
An observational study of Early Release of Chromogranin A (CgA), run by Military Institute od Medicine National Research Institute.
Trial summary
The results of the study suggest that an early change in CgA levels might serve as a prognostic factor in NET patients treated with PRRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Release of Chromogranin A (CgA)
- What is being tested?
- early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Sep 2023
- How long will I take part?
- 80 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).
Who may be able to join
- confirmed NET
- peptide receptor radionuclide therapy (PRRT)
Who cannot join
- lack of patient consent to a clinical trial
About this study
The results of the study suggest that an early change in CgA levels might serve as a prognostic factor in NET patients treated with PRRT.
- Conditions
- Early Release of Chromogranin A (CgA)
- Being tested
- early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).Diagnostic test
early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).
| Study group | Role | What they receive |
|---|---|---|
| patients with neuroendocrine tumours | We aimed to assess the predictive value of early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT). Receives: Diagnostic Test: early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The CgA level change
We aimed to assess the predictive value of early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).
Measured: 2016-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 Oct 2016
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Release of Chromogranin A (CgA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 80 Years
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrzej Mazurek, MD, Principal investigator, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183047
- Sponsor's protocol ID
- CgA dynamics
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Early Changes of Chromogranin A Levels in Patients With Neuroendocrine Tumours Treated With PRRT
- ClinicalTrials.gov ID
- NCT06183047
- Acronym / sponsor ID
- CgA dynamics
- Conditions
- Early Release of Chromogranin A (CgA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The results of the study suggest that an early change in CgA levels might serve as a prognostic factor in NET patients treated with PRRT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 80 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with neuroendocrine tumours | – | Diagnostic Test: early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).We aimed to assess the predictive value of early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).
Key inclusion criteria (2 listed)
- confirmed NET
- peptide receptor radionuclide therapy (PRRT)
Key exclusion criteria (1 listed)
- lack of patient consent to a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT). | Diagnostic test | patients with neuroendocrine tumours |
Primary outcome
The CgA level change
Time frame: 2016-2023
We aimed to assess the predictive value of early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Mazurek, MD principal investigator
Military Institute of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Early Release of Chromogranin A (CgA), run by Military Institute od Medicine National Research Institute.
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 2 inclusion and 1 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The CgA level change (time frame: 2016-2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2023.