Neuroendocrine TumorsNCT02815969
The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This is an observational and exploratory study. Participants will be asked for a blood collection and a 24- hour collection of urine. The indol profile and levels of catecholamine and metabolites in PRP, as well as in 24- hour collection of urine will be measured with LC-MS/MS and analyzed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- vena punction
- How many people
- 210 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Aug 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with foregut NET, patients with a midgut and/or hindgut NET, and healthy volunteers. All patients will be included in one of the groups by a dedicated NET doctor based on a combination of physical symptoms and signs, laboratory values, imaging and histology.
Who may be able to join
- written informed consent
- age above 18 years
- histologically proven NET, with or without treatment for the NET
- a diagnosis made by a dedicated NET specialist based on a combination of physical symptoms and signs, imaging and laboratory values.
- Matching in age (plus or minus 3 years) and sex with one of the included NET patients.
- Data of healthy subjects could also be used from the SERT-study, if the subject meets the criteria mentioned above.
Who cannot join
- Use of drugs or food supplements that interact with the serotonin-metabolism; all serotonin re-uptake inhibitors, psychotrophic drugs, (other antidepressants; tricyclic antidepressants, MAO-inhibitors, mirtazapin, bupropion, venlafaxin, duloxetin, anxiolytic, antipsychotic and anticonvulsive drugs).
- Drug abuse in the last 8 weeks.
- Use of ≥ 14 alcoholic consumptions a week for women.
- Use of ≥ 21 alcoholic consumptions a week for men.
- Having a neuroendocrine tumor or neuroendocrine carcinoma from any grade and location in present or in history.
- Having a malignancy.
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- Having an auto-immune disease.
- Having an infection.
- Having renal impairment.
- Use of interferon.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Metabolic Profile of Neuroendocrine Tumors
This is an observational and exploratory study. Participants will be asked for a blood collection and a 24- hour collection of urine. The indol profile and levels of catecholamine and metabolites in PRP, as well as in 24- hour collection of urine will be measured with LC-MS/MS and analyzed.
Read the detailed description
Rationale:
Neuro-endocrine neoplasms are a diverse group of tumors which encompasses heterogeneous clinical courses. Different NETs are characterized by differences in the synthesis, storage and release of biogenic amines and their metabolites, e.g. indoles, catecholamines and their metabolites. Clinical course, prognosis, and treatment are based, among others, on the origin of the primary tumor. Up to now it was only possible to measure metabolic output of NETs by serotonin in platelets and 5-HIAA in urine. Due to technical improvements we can now measure the complete metabolic pathway of serotonin in plasma and urine, which comprises tryptophan, 5-hydroxytryptophan, serotonin and 5-HIAA, the indol profile. Furthermore, levels of catecholamines and metabolites can now be analyzed in the same sample. This metabolic profiling could potentially lead to improved diagnosis and characterization of NET patients and possibly contribute to subsequent treatment consequences.
Therefore, we want to perform an exploratory study to measure the indol profile, catecholamines and metabolites in patients with NETs of different origin (foregut, midgut and hindgut) and assess differentiation of their metabolic profile.
Objective:
The aim of this study is to explore the added value of the indol profile in comparison to serotonin in platelets and 5-HIAA in urine for diagnosis and potentially management of neuroendocrine tumors including gastrinomas, pNETs and brochopulmonary NETs.
Design:
This is an observational and exploratory study. Participants will be asked for a blood collection and a 24- hour collection of urine. The indol profile and levels of catecholamine and metabolites in PRP, as well as in 24- hour collection of urine will be measured with LC-MS/MS and analyzed.
Study population:
In this study we will use PRP and a 24- hour collection of urine of 70 patients with a foregut NET, 70 patients with a midgut and/or hindgut NET and 70 matched healthy volunteers. Healthy volunteers are matched according to age and sex with the included patients. Matched controls already available in our data bank will be used from the earlier approved SERT study (NCT 01398306)
Main study parameters:
In this exploratory study we will measure the indol profile in patients with a foregut NET, mid- and hindgut NET, and healthy volunteers at the time of diagnosis and during follow up and treatment in plasma and urine.
In addition, levels of catecholamines and metabolites in these three groups will be determined.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients with midgut NET already have blood collections and urinary collection as part of evaluation of their treatment. Only for patients with foregut NETs and some of the healthy volunteers one extra blood collection with a vena puncture will be taken. This gives a small risk of bruising. Furthermore a 24-hours collection of urine will be collected with a prescription to their diet 48 hours before the collection. This could give some distress.
- Conditions
- Neuroendocrine Tumors
- Being tested
- vena punction
- Keywords
- neuroendocrine tumors, indol profile, catecholamines, LC-MS/MS
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vena punctionOther
vena punction and urine collection
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | If no material of healthy volunteers of the SERT study can be used, then other matched volunteers are asked for a vena punction and urine collection Receives: Other: vena punction | |
| Patients | Patients are asked for a vena punction and urine collection, if not already done because of medical care. Receives: Other: vena punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma
indol profile in platelet rich plasma
Measured: at one visit
Secondary outcomes (2)
catecholamines; L-DOPA, Dopamine, Norepinephrine, Epinephrine, -Methoxytyramine, Normetanephrine, Metanephrine in platelet rich plasma
catecholamines in platelet rich plasma
Measured: at one visit
indoles and catecholamines; L-DOPA, 5-HTP, Dopamine, Norepinephrine, Epinephrine, 3-Methoxytyramine, Normetanephrine, Metanephrine, Serotonin, 5-Hydroxyindolacetic acid
indoles and catecholamines in urine
Measured: at one visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. M.E. Walenkamp, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815969
- Sponsor's protocol ID
- 201600496
- Status last verified
- May 2024
- First submitted
- 21 Jun 2016
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Metabolic Profile of Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02815969
- Acronym / sponsor ID
- 201600496
- Conditions
- Neuroendocrine Tumors
- Keywords
- neuroendocrine tumors, indol profile, catecholamines, LC-MS/MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
This is an observational and exploratory study. Participants will be asked for a blood collection and a 24- hour collection of urine. The indol profile and levels of catecholamine and metabolites in PRP, as well as in 24- hour collection of urine will be measured with LC-MS/MS and analyzed.
Detailed description
Rationale:
Neuro-endocrine neoplasms are a diverse group of tumors which encompasses heterogeneous clinical courses. Different NETs are characterized by differences in the synthesis, storage and release of biogenic amines and their metabolites, e.g. indoles, catecholamines and their metabolites. Clinical course, prognosis, and treatment are based, among others, on the origin of the primary tumor. Up to now it was only possible to measure metabolic output of NETs by serotonin in platelets and 5-HIAA in urine. Due to technical improvements we can now measure the complete metabolic pathway of serotonin in plasma and urine, which comprises tryptophan, 5-hydroxytryptophan, serotonin and 5-HIAA, the indol profile. Furthermore, levels of catecholamines and metabolites can now be analyzed in the same sample. This metabolic profiling could potentially lead to improved diagnosis and characterization of NET patients and possibly contribute to subsequent treatment consequences.
Therefore, we want to perform an exploratory study to measure the indol profile, catecholamines and metabolites in patients with NETs of different origin (foregut, midgut and hindgut) and assess differentiation of their metabolic profile.
Objective:
The aim of this study is to explore the added value of the indol profile in comparison to serotonin in platelets and 5-HIAA in urine for diagnosis and potentially management of neuroendocrine tumors including gastrinomas, pNETs and brochopulmonary NETs.
Design:
This is an observational and exploratory study. Participants will be asked for a blood collection and a 24- hour collection of urine. The indol profile and levels of catecholamine and metabolites in PRP, as well as in 24- hour collection of urine will be measured with LC-MS/MS and analyzed.
Study population:
In this study we will use PRP and a 24- hour collection of urine of 70 patients with a foregut NET, 70 patients with a midgut and/or hindgut NET and 70 matched healthy volunteers. Healthy volunteers are matched according to age and sex with the included patients. Matched controls already available in our data bank will be used from the earlier approved SERT study (NCT 01398306)
Main study parameters:
In this exploratory study we will measure the indol profile in patients with a foregut NET, mid- and hindgut NET, and healthy volunteers at the time of diagnosis and during follow up and treatment in plasma and urine.
In addition, levels of catecholamines and metabolites in these three groups will be determined.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients with midgut NET already have blood collections and urinary collection as part of evaluation of their treatment. Only for patients with foregut NETs and some of the healthy volunteers one extra blood collection with a vena puncture will be taken. This gives a small risk of bruising. Furthermore a 24-hours collection of urine will be collected with a prescription to their diet 48 hours before the collection. This could give some distress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: vena punctionIf no material of healthy volunteers of the SERT study can be used, then other matched volunteers are asked for a vena punction and urine collection |
| Patients | – | Other: vena punctionPatients are asked for a vena punction and urine collection, if not already done because of medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with foregut NET, patients with a midgut and/or hindgut NET, and healthy volunteers. All patients will be included in one of the groups by a dedicated NET doctor based on a combination of physical symptoms and signs, laboratory values, imaging and histology.
Key inclusion criteria (6 listed)
- written informed consent
- age above 18 years
- histologically proven NET, with or without treatment for the NET
- a diagnosis made by a dedicated NET specialist based on a combination of physical symptoms and signs, imaging and laboratory values.
- Matching in age (plus or minus 3 years) and sex with one of the included NET patients.
Key exclusion criteria (10 listed)
- Use of drugs or food supplements that interact with the serotonin-metabolism; all serotonin re-uptake inhibitors, psychotrophic drugs, (other antidepressants; tricyclic antidepressants, MAO-inhibitors, mirtazapin, bupropion, venlafaxin, duloxetin, anxiolytic, antipsychotic and anticonvulsive drugs).
- Drug abuse in the last 8 weeks.
- Use of ≥ 14 alcoholic consumptions a week for women.
- Use of ≥ 21 alcoholic consumptions a week for men.
- Having a neuroendocrine tumor or neuroendocrine carcinoma from any grade and location in present or in history.
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 |
|---|---|---|
| vena punctionvena punction and urine collection | Other | Healthy volunteers, Patients |
Primary outcome
indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma
Time frame: at one visit
indol profile in platelet rich plasma
2 secondary outcomes
catecholamines; L-DOPA, Dopamine, Norepinephrine, Epinephrine, -Methoxytyramine, Normetanephrine, Metanephrine in platelet rich plasma
Time frame: at one visit
indoles and catecholamines; L-DOPA, 5-HTP, Dopamine, Norepinephrine, Epinephrine, 3-Methoxytyramine, Normetanephrine, Metanephrine, Serotonin, 5-Hydroxyindolacetic acid
Time frame: at one visit
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 6 May 2024.
- Individual participant dataSharing planned: No
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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.
A. M.E. Walenkamp, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by University Medical Center Groningen at 1 site in Netherlands.
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 6 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma (time frame: at one visit). 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 6 May 2024.