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NEOSENT: Early Anti-PD-1 Therapy In High-Risk Stage II Melanoma (NEOSENT)

26. juni 2026 opdateret af: AC Camargo Cancer Center

NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And/Or Microsatellitosis: An Ambispective Observational Cohort Study

This is an observational cohort study evaluating clinical and pathological outcomes in patients with high-risk stage II melanoma.

Patients are included after receiving treatment as part of routine clinical practice. Decisions about treatment, including whether to start anti-PD1 therapy before surgery, are made by the treating physician and are not influenced by the study.

The study compares outcomes between patients who started anti-PD1 therapy before surgery and those treated according to the usual timing in clinical practice.

No treatments are assigned as part of the study.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study evaluates the association between the timing of anti-PD1 therapy initiation and clinical outcomes in patients with high-risk stage II melanoma (stages IIB and IIC) and/or microsatellitosis.

The study is designed as an ambispective observational cohort, including both retrospective and prospective patients treated in routine clinical practice.

The retrospective cohort includes patients who were managed according to standard clinical practice, typically undergoing surgical treatment followed by systemic/adjuvant anti-PD1 therapy. The prospective cohort includes patients who initiated anti-PD1 therapy prior to surgery, based on the treating physician's clinical judgment.

All treatment decisions, including the timing of systemic therapy initiation, are made independently by the treating physician and are not influenced by the study protocol. No interventions are assigned as part of the study, and no experimental treatment strategies are implemented.

Patients are categorized according to the timing of anti-PD1 therapy initiation (before surgery or according to standard timing), and outcomes are compared descriptively between these groups.

The study aims to explore whether early initiation of systemic therapy in routine clinical practice is associated with differences in time to treatment initiation and key clinical outcomes, including recurrence-free survival, overall survival, and pathological response.

Given its observational design, the study does not aim to establish causality but rather to generate real-world evidence regarding the potential impact of early anti-PD1 therapy in this high-risk population. As a non-randomized observational study, the results may be subject to confounding factors and selection bias inherent to real-world clinical practice.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients with high-risk stage II cutaneous melanoma (stages IIB and IIC) and/or microsatellitosis treated in routine clinical practice.

Beskrivelse

Inclusion Criteria:

- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.

Exclusion Criteria:

  • Patients without sufficient clinical or follow-up data.
  • Patients who do not provide informed consent (for prospective cohort).

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
Early Anti-PD1 Therapy Before Surgery
Patients who initiated anti-PD1 therapy prior to surgery, based on routine clinical decision-making. Group classification is based on the timing of anti-PD1 therapy initiation in relation to surgical treatment.
Andet: Anti-PD1 Therapy Timing
This is an observational study variable. The timing of anti-PD1 therapy initiation in relation to surgery is determined by the treating physician as part of routine clinical practice. The study does not assign or modify any treatment.
Standard Timing Group
Patients who underwent surgery followed by systemic/adjuvant anti-PD1 therapy according to standard clinical practice. Group classification is based on the timing of anti-PD1 therapy initiation in relation to surgical treatment.
Andet: Anti-PD1 Therapy Timing
This is an observational study variable. The timing of anti-PD1 therapy initiation in relation to surgery is determined by the treating physician as part of routine clinical practice. The study does not assign or modify any treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to initiation of systemic therapy
Tidsramme: Up to 12 months
Time from date of diagnosis to the start of systemic or adjuvant therapy.
Up to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AC Camargo Cancer Center

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 (Faktiske)

23. april 2025

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NEOSENT-ACC-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Kutant melanom

Kliniske forsøg med Anti-PD1 Therapy Timing

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner