- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07748169
An Observational Study of Patients With Dermatologic Disease (TARGET-DERM+)
8. september 2026 opdateret af: Target PharmaSolutions, Inc.
TARGET-DERM+ is an observational research study to conduct a comprehensive review of outcomes for patients with dermatologic disease (DD) and providers who treat these patients.
The study includes patients managed for DD of any etiology in usual clinical practice in the United States and addresses important clinical questions regarding the management of DD by collecting and analyzing data from patients at academic medical centers and community medical practices and/or data from providers who treat them.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
TARGET-DERM+ is an observational research study to conduct a comprehensive review of outcomes for patients with dermatologic disease (DD) and providers who treat these patients.
The study includes patients managed for DD of any etiology in usual clinical practice in the United States and addresses important clinical questions regarding the management of DD by collecting and analyzing data from patients at academic medical centers and community medical practices and/or data from providers who treat them.
TARGET-DERM+ is designed to develop a large, robust database of real-world data regarding the natural history, management, and health outcomes related to the care of DD of diverse etiologies and practice settings.
The study is also designed to establish learning health networks focused on quality of care for patients with DD.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
2000000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Lynda Lee Burch
- Telefonnummer: 9842340268
- E-mail: lburch@pedestalhealth.com
Undersøgelse Kontakt Backup
- Navn: Laura Dalfonso
- Telefonnummer: 9842340268
- E-mail: ldalfonso@pedestalhealth.com
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10012
- Greenwich Village Dermatology
-
Kontakt:
- Jasmina Jeter
- Telefonnummer: 212-385-3700
- E-mail: jjeter@thedermspecs.com
-
Ledende efterforsker:
- Andrew Peranteau
-
-
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
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
2,000,000
Beskrivelse
Inclusion Criteria:
- Adult or pediatric participants managed for DD invited to participate OR a provider who treats patients with these conditions. Informed consent is required for all Engaged Cohort participants.
- Adult or pediatric participants at the time of enrollment with a diagnosis of DD by ICD code or other relevant healthcare code as part of the EHR interface.
Exclusion Criteria:
- Participant withdrew consent; Failure to complete activities as required per the cohort clarification letter.
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 |
|---|
|
Disease Cohort
Adult patients and patients under the age of majority with a diagnosis of DD by ICD or other relevant healthcare code in the EHR interface.
|
|
Engaged Cohort
Adult patients and patients under the age of majority diagnosed and managed for DD invited to participate OR HCPs who treat patients with these conditions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess safety and effectiveness of DD treatments and treatments for complications of any dermatologic disease
Tidsramme: 15 years
|
The study will evaluate the characteristics of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for DD
|
15 years
|
|
To characterize the natural history of disease in patients with dermatologic disease from various etiologies
Tidsramme: 15 years
|
A detailed analysis of available demographics (age, race, sex, country of birth, insurance status), medications, co-morbidities, and medical history from sites across the US will inform the profile for this patient population.
|
15 years
|
|
To establish learning health networks focused on quality of care for patients
Tidsramme: 15 years
|
Identify deficiencies and best practices in care of patients with DD. • Evaluate outcomes from targeted learning content in the management of patients with DD. |
15 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate provider management practices in the treatment of patients with DD
Tidsramme: 15 years
|
Health care provider type, clinic setting, reason for initiating/not initiating/adjusting dosing of treatments, reason for discontinuing/switching treatments, and monitoring outcomes on and off treatment, will be captured as available in the provided EHR and/or through linked data.
|
15 years
|
|
To evaluate longitudinal and patient reported outcomes in DD
Tidsramme: 15 years
|
Longitudinal clinical outcomes and disease progression will be assessed.
Self-reported patient health measures collect information directly from patients to measure physical, mental, and social health.
|
15 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Laura Dalfonso, Pedestal Health
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 (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
3. august 2041
Studieafslutning (Anslået)
3. august 2041
Datoer for studieregistrering
Først indsendt
21. juli 2026
Først indsendt, der opfyldte QC-kriterier
31. juli 2026
Først opslået (Faktiske)
5. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Genetiske sygdomme, medfødte
- Sygdomme i immunsystemet
- Infektioner
- Overfølsomhed, Øjeblikkelig
- Overfølsomhed
- Alopeci
- Hypotrikose
- Hårsygdomme
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Svedkirtelsygdomme
- Hudsygdomme, bakteriel
- Hudsygdomme, smitsom
- Suppuration
- Hypopigmentering
- Pigmenteringsforstyrrelser
- Hudsygdomme, genetisk
- Hudsygdomme, eksem
- Dermatitis
- Hidradenitis
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Hud- og bindevævssygdomme
- Alopecia areata
- Hidradenitis Suppurativa
- Vitiligo
- Dermatitis, atopisk
- Hudsygdomme
Andre undersøgelses-id-numre
- TARGET-DERM+
Plan for individuelle deltagerdata (IPD)
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