Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery (Intense-CT)

19. december 2018 opdateret af: McMaster University

Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery: A Pilot Study for the Intense-CT Trial

After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or development of a new cancer. Historically, patients who have undergone curative lung cancer surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients still die of lung cancer. As a result, there has been interest in other methods of surveillance in order to detect recurring or new cancers earlier and have more success in treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently the standard of care and surveillance at this institution. This pilot study aims to determine whether regimented, intensive, short interval LDCT surveillance leads to higher rates of detection and treatment of recurring lung cancers. The study group will be followed up according to a regimented surveillance program using LDCT. The study group will be compared to a group of historical controls whose follow up after surgery was not standardized, but rather left up to the discretion of the individual surgeon. If the results of this study show improvements in detection and treatment of recurrent cancers, it will allow for a larger trial to study the effects of the LDCT surveillance program on lung cancer survival.

The study question aims to determine whether for survivors after curative surgery for Stage I and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the rate of detection and treatment of recurring or new cancers when compared to historical non-structured surveillance with CXR. This study will also determine if it is warranted to pursue a larger scale randomized controlled trial to further investigate optimal LDCT surveillance follow-up intervals and long-term lung cancer survival.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

313

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients must be at minimum 18 years of age
  • Patients must have undergone complete resection for pathological Stage I or Stage II lung cancer
  • Patients must demonstrate the ability to understand English
  • Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures

Exclusion Criteria:

  • Patients with residual gross or microscopic disease after surgery
  • Patients with pathological Stage III or Stage IV lung cancer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: LDCT Surveillance Program Group
This cohort will follow a strict schedule of Low Dose Computed Tomography Imaging scans and clinical visits 3, 6, and 12 months after surgery. At each encounter, a history, physical examination, and review of the LDCT results will be performed. Patients with normal clinical and imaging findings will proceed to the next scheduled clinical encounter. Patients with abnormal findings will be managed according to predetermined algorithms.
Procedure: Low Dose Computed Tomography Imaging
Andet: Historical Control Group
The control group will be a retrospective cohort taken from 1-year before the implementation of the LDCT surveillance program. The post-operative follow-up of these participants was not standardized, but rather left up to the discretion of the individual surgeons, and involved chest radiograph imaging as opposed to Low Dose Computed Tomography.
Procedure: Chest Radiograph Imaging

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of therapeutic re-intervention within the first year after curative resection of lung cancer
Tidsramme: One year after surgery
Defined by: 1) rate of curative intent radiation treatment after detection of recurrent or new primary lung cancer 2) rate of curative intent reoperation after detection of recurrent or new primary lung cancer. Measured by frequency of events.
One year after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of adherence to follow-up visits
Tidsramme: One year after surgery
Measured by frequency of events
One year after surgery
Morbidity of associated interventions
Tidsramme: One year after surgery
Measured by frequency of events
One year after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

McMaster University

Samarbejdspartnere

McMaster Surgical Associates

Efterforskere

  • Ledende efterforsker: Wael C Hanna, MDCM MBA FRCSC FCCP, McMaster University

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)

1. august 2014

Primær færdiggørelse (Faktiske)

30. april 2018

Studieafslutning (Faktiske)

30. april 2018

Datoer for studieregistrering

Først indsendt

20. maj 2014

Først indsendt, der opfyldte QC-kriterier

23. maj 2014

Først opslået (Skøn)

29. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SJHH_IntenseCT_Pilot

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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 Lungeneoplasmer

Kliniske forsøg med Low Dose Computed Tomography Imaging

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Africa

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner