Neurokutan melanocytoseregister
Prospektivt register over patienter med neurokutan melanocytose (NCM) inklusive kutan og CNS-involvering
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yasmin Khakoo, MD
- Telefonnummer: 212-639-8292
- E-mail: khakooy@mskcc.org
Undersøgelse Kontakt Backup
- Navn: Sofia Haque, MD
- Telefonnummer: 212-639-7170
- E-mail: haques@MSKCC.ORG
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Ikke rekrutterer endnu
- Boston Children's Hospital (Data Analysis Only)
-
Kontakt:
- Elena Hawryluk, MD
- Telefonnummer: 617-355-6117
-
-
New York
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Kontakt:
- Yasmin Khakoo, MD
- Telefonnummer: 212-639-8292
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
A target sample of 75 patients with LCMN and/or NCM will be enrolled in this registry study. The study is expected to accrue over ≥ 7 years. Currently, an estimated 50 LCMN patients are followed at MSK and we anticipate 25 or more to be referred from outside providers or from new patients seen at MSK. The patient population and the MSK referral base is growing at this time, making this enrollment goal as feasible.
Beskrivelse
Inclusion Criteria:
-
Patients with LCMN, defined as:
- Dark-colored patch of skin present at birth
- Can be located anywhere on the individual's skin
- May include satellite lesions
- May be associated with hypertrichosis
OR, in absence of cutaneous involvement:
-
histologically or radiographically confirmed CNS melanocytosis.
- Any age at diagnosis.
- Signed informed consent by a patient, or parent/legal guardian.
- Deceased patients can be included provided that parent/legal guardian is contacted at least 6 months after the death of the child and not on the child's birthday or anniversary of death.
Pathology review at MSK is not mandatory to confirm the diagnosis of LCMN or NCM. We will not require pathology analysis of leptomeningeal deposits in patients where characteristic skin lesions are present and melanosis of the meninges is radiographically evident. However, if pathology samples have already been obtained as part of a patient's evaluation and treatment at another institution, tissue samples will be requested for review and confirmation of the diagnosis.
Exclusion Criteria:
- Informed consent has not been provided.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Neurocutaneous Melanocytosis
Participants will have Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Indsaml retrospektive og prospektive kliniske, behandlings- og resultatdata om patienter med neurokutan melanocytose (NCM) på verdensplan
Tidsramme: Op til 7 år
|
Op til 7 år
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Yasmin Khakoo, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20-363
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .