- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02406352
Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia (MDCwProbe)
Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device mounted on a custom-made colposcope that acquires a sequence of fluorescence images. This version of the MDC incorporates an upgraded light source, and updates the firmware and the user interface. This results in shorter acquisition times and improved image and spectrum quality control. The MDC also consists of a point probe that is used to take detailed light measurements (call spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the MDC can perform better than standard methods in detecting cancerous or pre-cancerous abnormalities of the cervix.
Study subjects will be swabbed for detection and typing of the Human Papilloma Virus (HPV). After vinegar is applied on the cervix as per usual colposcopy practice, the MDC will then be used to take a sequence of images of the cervix. Next 2-4 readings will be taken from the cervix using the point probe.
This data will be used to train, test and validate an algorithm specific to the MDC. The ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC probe. The investigators will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Leonid Fradkin, PhD
- Telefonnummer: 718-240-8225
- E-post: lfradkin@bhmcny.org
Studer Kontakt Backup
- Navn: Thelma Carrillo, MPH
- Telefonnummer: 718-240-5978
- E-post: tcarrill@bhmcny.org
Studiesteder
-
-
New York
-
Brooklyn, New York, Forente stater, 11212
- Rekruttering
- Brookdale University Hospital and Medical Center
-
Ta kontakt med:
- Leonid Fradkin, PhD
- Telefonnummer: 718-240-8225
- E-post: lfradkin@bhmcny.org
-
Ta kontakt med:
- Thelma Carrillo, MPH
- Telefonnummer: 718-240-5978
- E-post: tcarrill@bhmcny.org
-
Hovedetterforsker:
- Michele Follen, MD, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Women who are at least 18 years old
- Are not pregnant (negative urine test) or breastfeeding
- Referred for colposcopy or LEEP treatment
- Can provide written informed consent
Exclusion Criteria:
- Women who do not meet the inclusion criteria
- Women who have had a hysterectomy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Routine colposcopy and MDC with probe
The intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure.
A control biopsy will also be obtained from patients who agree to provide it.
The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope.
|
Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study. The standard of care for research participants will not change. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Detection of precancerous cervical lesions or cervical cancer
Tidsramme: At point of care for colposcopy or treatment with LEEP (5 minutes).
|
Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care. Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied. |
At point of care for colposcopy or treatment with LEEP (5 minutes).
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Michele Follen, MD, PhD, Brookdale University Hospital and Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-35
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Karsinom in situ av livmorhalsen
-
Mithra PharmaceuticalsFullførtIntraepitelial neoplasi i livmorhalsen | Uterin cervikal neoplasiBelgia
-
Peking University Cancer Hospital & InstituteUkjentEsophageal plateepitelkarsinom | Mild dysplasi i spiserøret | Moderat dysplasi i spiserøret | Alvorlig dysplasi i spiserøret | Carcinoma in situ of esophagusKina
-
University Hospitals Cleveland Medical CenterFullførtLivmor livmorhalsdysplasi | Livmor livmorhalskreft | Uterin cervikal neoplasi | Uterine Cervical Intraepithelial Neoplasia
-
University of AarhusFullførtUterine cervikale neoplasmer | Livmor livmorhalsdysplasi | Normal uterin cervikal cytologiDanmark
-
UNC Lineberger Comprehensive Cancer CenterHar ikke rekruttert ennåLivmorhalskreft | Cervix Intraepitelial Neoplasia Grad 3 | Livmorhalsen; Intraepitelial neoplasi, grad I | Livmorhalsen; Intraepitelial neoplasi, grad IIKenya
-
Alkü Alanya Education and Research HospitalUkjentEndometriehyperplasi | Uterin fibroid | Cervikal dysplasi | EggstokkcysteTyrkia
-
University Hospital, ToursFullførtKjønnssykdommer, kvinner | Livmorprolaps | Dysfunksjonell livmorblødning | Cervikal dysplasi | Hysterotomi; Påvirker fosteret | Leiomyomata Uteri | Adenomyose, EndometrioseFrankrike
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage IV prostatakreft AJCC v8 | Hepatobiliær neoplasma | Stadium III nyrecellekreft AJCC v8 | Stadium IV nyrecellekreft AJCC v8 | Stage III Livmor Corpus Cancer AJCC v8 | Stage IV Livmor Corpus Cancer AJCC v8 | Stage IVA Livmor Corpus Cancer AJCC v8 | Stadium IVB Uterine Corpus Cancer AJCC v8 | Ondartet... og andre forholdForente stater