Clinical trial · Observational
The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
Exploring the Metabolic Profile of Neuroendocrine Tumors
NCT02815969CI-TRIAL-00076803completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vena punction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Healthy volunteers
- description
- 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
- interventionNames
- Other: vena punction
- label
- Patients
- description
- Patients are asked for a vena punction and urine collection, if not already done because of medical care.
- interventionNames
- Other: vena punction
Primary outcomes (1)
- measure
- indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma
- timeFrame
- at one visit
- description
- indol profile in platelet rich plasma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria for all subjects: * written informed consent * age above 18 years Inclusion criteria for patients with a NET: (one of these) * 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. Inclusion criteria for healthy subjects: \- 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. Exclusion criteria for all subjects: * 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. Exclusion criteria for healthy subjects: * Having a neuroendocrine tumor or neuroendocrine carcinoma from any grade and location in present or in history. * Having a malignancy. * Having an auto-immune disease. * Having an infection. * Having renal impairment. * Use of interferon.
References
Publications (0)
Data not yet available
No reference posted for this study.