- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02075905
Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management
Studieöversikt
Status
Detaljerad beskrivning
The Investigators have previously completed a validation study in which they have identified a panel of biomarkers that can predict progression of subjects with BE and no dysplasia or low-grade dysplasia to esophageal adenocarcinoma (EAC). The biomarker panel, performed by the Fitzgerald lab, included ploidy (by image cytometry), AOL (histochemistry (IHC)), p53 (IHC), cyclin A (IHC), and dysplasia. These markers have been validated and demonstrated to be highly predictive of both progression to EAC, as well as the presence of occult malignancy elsewhere in the specimen (field effect). The final panel of validated biomarkers will be used in this study to identify patients at high risk of developing EAC.
The study will recruit 100 patients across 4 sites (University of North Carolina, Case Western Reserve University, University of Cambridge, and Academic Medical Center in Amsterdam). The specific aims of this pilot study are to:
- Demonstrate that the international, multicenter team can work together,
- Define the logistics of assaying biomarkers in real time such that in the future interventional trial, results could influence clinical decision-making, and,
- Provide further data to inform a power calculation for the full trial.
Subjects enrolled in the study will complete a questionnaire gathering hypothetical willingness to be randomized to receive endoscopic treatment intervention (RFA) or surveillance endoscopy.
Biopsy samples will be obtained from all subjects and tested for all biomarkers in the panel. Results of the biomarker panel will not be communicated to sites. Subjects with low grade dysplasia will be offered the option of receiving radiofrequency ablation (RFA) as part of routine care. Subjects with low grade dysplasia who agree to RFA will receive RFA as part of routine care. Subjects with no dysplasia and subjects with low grade dysplasia who do not want to receive RFA will receive a surveillance endoscopy in 1 year as part of routine care.
The goals of this pilot study are to ascertain the proportion of subjects in the high risk arm, to demonstrate the plausibility of performing the biomarker analysis efficiently in a sizable group of patients, to demonstrate the feasibility of delivering the endoscopic intervention (RFA), to obtain 1 year pilot data regarding progression in the high risk arm for use in sample size calculations, and to document collaboration among the centers.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- University Of North Carolina At Chapel Hill
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve University
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Amsterdam, Nederländerna, 1100 DD
- Academic Medical Center
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Cambridge, Storbritannien, CB2 0XZ
- University of Cambridge
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Able to read, comprehend, and complete the consent form.
- Aged 18 to 80.
- Diagnosed with at least 3 centimeters (>3cm) of Barrett's Esophagus (BE) AND no dysplasia or low grade dysplasia per review by pathologist.
Exclusion Criteria:
- Pregnant women.
- Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after EGD).
- Known bleeding disorder.
- Status post partial or complete esophageal resection.
- Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
- Prior ablative therapy of the esophagus including prior radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, and other ablation therapies. Prior endoscopic mucosal resection (EMR) is acceptable.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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Barrett's Esophagus-Low Grade Dysplasia
Subjects enrolled who have Barrett's Esophagus with low grade dysplasia.
No research intervention is administered.
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Barrett's Esophagus-no dysplasia
Subjects enrolled with Barrett's Esophagus and no dysplasia.
No research intervention is administered.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Risk Stratification
Tidsram: Baseline
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This is a pilot study the main objective of which is to determine feasibility and preparation for a larger scale study.
Baseline tissue samples will be used to stratify subjects as either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results.
Biomarker panel risk stratification will be compared to data collected 1 year post enrollment regarding current pathology and ablation treatments received since enrollment.
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Baseline
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Nicholas J Shaheen, MD, MPH, UNC-Chapel Hill
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13-3843
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Kliniska prövningar på Barretts matstrupe
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Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA IncorporatedAvslutadBarretts matstrupe | Höggradig dysplasi i Barrett Esophagus | Låggradig dysplasi i Barrett EsophagusFörenta staterna
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University Medical Center GroningenAvslutadMatstrupscancer | Barrett Esophagus | Dysplasi i Barrett EsophagusNederländerna
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International Agency for Research on CancerUniversity of Cambridge; Kilimanjaro Clinical Research InstituteAvslutad
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Nantes University HospitalRekryteringBarrett EsophagusFrankrike
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Columbia UniversityNational Cancer Institute (NCI); University of MichiganRekrytering
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Professor Michael BourkeRekryteringBarretts matstrupeAustralien
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Dallas VA Medical CenterAvslutad
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Massachusetts General HospitalNational Cancer Institute (NCI)AvslutadBarretts matstrupeFörenta staterna
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)Aktiv, inte rekryterandeBarretts matstrupeFörenta staterna
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University of MichiganAvslutadBarrett EsophagusFörenta staterna