Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation
23. januar 2017 opdateret af: Universitaire Ziekenhuizen KU Leuven
Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation by Human Serum
This is a prospective biobank set up to collect serum from patients with disorders associated with changes in androgens, estrogens or sex hormone-binding globulin (SHBG), before and/or after treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In vitro cell-based bioassays may be a technique to measure serum androgen or estrogen bioactivity. In this study investigators are collecting serum (and if possible, urine) samples from different cohorts of patients, before and/or after treatment.
The aim is to measure androgens, estrogens and SHBG as well as in vitro bioactivity with newly developed cell-based bioassays, and to compare different techniques to each other as well as to clinical endpoints available in the patient's Electronic Health Record.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
73
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients in the department of Endocrinology/Andrology, Urology and Oncology
Beskrivelse
Inclusion Criteria:
- Known or expected medical condition affecting androgens, estrogens or SHBG
Exclusion Criteria:
- Inability to provide written informed consent
- Known or suspected bloodborne infectious diseases (e.g. HIV, viral hepatitis etc.)
- Anemia (<11 g/dL hemoglobin) or being a Jehovah's Witness
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Medical castration
Patients treated with androgen deprivation therapy (e.g. for hypersexuality, transgender subjects, ...)
|
|
|
Male hypogonadism
Patients treated with testosterone replacement therapy (e.g. for late-onset hypogonadism, secondary hypogonadism)
|
|
|
Thyroid disorders
Patients treated for hyperthyroidism or hypothyroidism (incl.
during treatment for thyroid cancer)
|
|
|
Obesity and weight loss
Patients treated for obesity with weight loss interventions (mainly bariatric surgery)
|
|
|
Miscellaneous
Various disorders associated with alterations in SHBG, androgens and/or estrogens
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Testosterone bioequivalents (in nanomolar)
Tidsramme: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
|
Estradiol bioequivalents (in picomolar)
Tidsramme: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Calculated free and bioavailable testosterone (in nanomolar)
Tidsramme: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
|
|
Calculated free and bioavailable estradiol (in picomolar)
Tidsramme: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
|
|
Total serum testosterone (in nanomolar)
Tidsramme: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
Measured by immunoassay or liquid chromatography tandem mass spectrometry (LC-MS/MS)
|
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
|
Total serum estradiol (in picomolar)
Tidsramme: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
Measured by immunoassay or LC-MS/MS
|
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
|
Total serum SHBG (in nanomolar)
Tidsramme: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
Measured by immunoassay
|
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Dirk Vanderschueren, MD, PhD, UZ Leuven
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2012
Primær færdiggørelse (Faktiske)
1. september 2016
Studieafslutning (Faktiske)
30. september 2016
Datoer for studieregistrering
Først indsendt
30. april 2015
Først indsendt, der opfyldte QC-kriterier
4. maj 2015
Først opslået (Skøn)
5. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. januar 2017
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- s54034
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .