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Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy (SUPE_R)

1. April 2022 aktualisiert von: Barbara Malene Fischer, Rigshospitalet, Denmark

Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial

The purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients. The investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body Positron Emission Tomography combined with Computer Tomography (PET/CT) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

750

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Dänemark
      • Copenhagen, Dänemark, 2100
        • Rigshospitalet
      • Gentofte, Dänemark, 2900
        • Gentofte Hospital
      • Herlev, Dänemark, 2730
        • Herlev Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Patient with non-small cell lung cancer (NSCLC), proven by cytology or histology
  • Patient in clinical stages I-III
  • Age≥ 18 years
  • Performance status ≤ 2 at the time of referral to therapy
  • Patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation).
  • Patient has given his/her written informed consent before any specific procedure from protocol

Exclusion Criteria:

  • Patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on CT.
  • Persons deprived of liberty or under guardianship or curators
  • Dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial
  • Pregnant or breastfeeding women
  • Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in SUPE-R. Participation in protocols related only to initial treatment will not preclude participation in SUPE-R. Cases of doubt will be settled by the steering committee.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A, PET/CT
18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) replacing computed tomography (CT) at months 6, 12, 18 and 24, otherwise as B with CT scan months 9, 15 and 21. Quality of life assessment and liquid biopsy every 3 months for later analysis.
Diagnosetest: Whole body 18F-FDG PET/CT
In the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment. A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment. All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months.
Kein Eingriff: Control arm B
CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of relapses treatable with curative intent
Zeitfenster: Until first detected relapse or 2 years after enrollment
As decided by multidisciplinary meetings
Until first detected relapse or 2 years after enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to verified relapse
Zeitfenster: From date of randomization until the date of first documented relapse assessed up to 24 months
Relapse verified by histology or imaging combined with MDM review
From date of randomization until the date of first documented relapse assessed up to 24 months
Overall survival
Zeitfenster: From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
Death of any course or censoring
From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
Overall survival for patients with relapse
Zeitfenster: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Death of any course or censoring
From randomization until 12 months after first detected relapse or until death (whichever comes first)
Performance status at relapse
Zeitfenster: From randomization until first detected relapse or 24 months
Performance status of study participants at relapse will be assessed using Eastern Cooperative Oncology Group (ECOG) performance status scale from grade 0 to grade 4, where grade 0 corresponds to a patient who is "fully active, able to carry on all pre-disease performance without restriction" and grade 4 is a patient who is "completely disabled; cannot carry on any selfcare; totally confined to bed or chair".
From randomization until first detected relapse or 24 months
Quality of life / QLQ-C30
Zeitfenster: From randomization until first detected relapse or 24 months

Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionaire Core Questionaire 30 (EORTC QLQ-C30).

The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").
From randomization until first detected relapse or 24 months
Quality of life / QLQ-LC13
Zeitfenster: From randomization until first detected relapse or 24 months

Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionair Lung Cancer 13 (EORTC QLQ-LC13).

The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").
From randomization until first detected relapse or 24 months
Quality of life / Raw score
Zeitfenster: From randomization until first detected relapse or 24 months
From the results of QLQ-C30 and QLQ-LC13 a Raw Score (RS) is calculated (average of all scores) and Quality of Life is calculated as (RS - 1)/3 which outputs a value between 0 and 1, where 0 is a complete absence of symptoms and 1 is the maximum severity of all related symptoms. This will be used for calculation of QALY in the cost-effectiveness analysis.
From randomization until first detected relapse or 24 months
Number of procedures to assess incidental findings
Zeitfenster: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Procedures resulting from an incidental finding on a follow up scan
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Types of procedures to assess incidental findings
Zeitfenster: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Invasive / non-invasive
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Adverse events due to invasive procedures done to assess incidental findings
Zeitfenster: From randomization until 24 months or first detected relapse or until death (whichever comes first)
For example: Bleeding, pneumothorax, hospital admission
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Cost-effectiveness analysis of intervention
Zeitfenster: From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
Cost-effectiveness of the PET/CT regimen vs the CT regimen is assessed with the ICER (incremental cost-effectiveness ratio), i.e. the ratio of net health care costs to net QALYs ( quality-adjusted life years). Net health care costs are estimated as the health care costs difference between the two arms and net QALYs likewise. Health care costs are calculated from register-based information on health care consumption cumulated in 2-yrs follow-up (DRG-rates) supplemented by intervention costs based on project costs. The relevant cost data are available at "Sundhedsdatastyrelsen" using their research service.
From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
Type of treatment after verification of relapse
Zeitfenster: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Description of treatment - e.g. surgical, radiotherapy, stereotactic ablative body radiotherapy, medical treatment
From randomization until 12 months after first detected relapse or until death (whichever comes first)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rigshospitalet, Denmark

Mitarbeiter

Danish Lung Cancer Group
Danish Comprehensive Cancer Center

Ermittler

  • Hauptermittler: Barbara M Fischer, MD PhD DMSci, Rigshospitalet, Denmark

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. Oktober 2018

Primärer Abschluss (Voraussichtlich)

1. August 2023

Studienabschluss (Voraussichtlich)

1. August 2026

Studienanmeldedaten

Zuerst eingereicht

25. Oktober 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. November 2018

Zuerst gepostet (Tatsächlich)

14. November 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. April 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-18009536

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Unentschieden

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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