Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
9. mars 2020 oppdatert av: University Health Network, Toronto
This research is being done to find out what types of gene mutations are present in people with cancer.
This study is designed to help researchers and doctors understand more about cancer.
With this information, doctors may have a better idea as to which cancer treatments are most appropriate for certain patients.
The information will also help researchers find out the how to identify genes in cancers from biopsies and blood samples and how to use this information to help doctors and patients make treatment decisions.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a prospective cohort study with the goal of obtaining fresh tumor biopsies and one blood sample from patients with a confirmed histological or cytological diagnosis of cancer, who are potential candidates for a phase I or II clinical trial at their local institution.
DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to targeted and genome-wide sequencing to enable molecular characterization of tumors.
Application of genomic information by investigators will be captured.
Archived tumor samples will be requested from all patients.
For patients with malignant ascites or pleural effusions, fluid and tumor samples will be evaluated.
Studietype
Observasjonsmessig
Registrering (Faktiske)
50
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients from the Princess Margaret Hospital or other Ontario Institution
Beskrivelse
Inclusion Criteria:
- Age > 18 years.
- Histological or cytological proof of solid tumour cancer.
- At least one biopsiable lesion deemed medically accessible and safe to biopsy.
- Candidate for one or more phase I or II clinical trials in the local institution or in another Ontario institution, at the time of study enrollment or at a later time point.
- Fulfills local institution's laboratory parameters for tumor biopsy.
- Willingness and ability of patient to provide signed voluntary informed consent.
Exclusion Criteria:
- Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
- Any contraindication to undergoing a biopsy procedure.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Solid Tumor Cancer
|
Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
Tidsramme: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Average and range of time (in calendar days) that occurred between study participants providing informed consent to the reporting of genomic results to the physician.
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Actionable Genomic Results
Tidsramme: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Number of participants with actionable genomic results (defined as having the potential to impact on management recommendations based on diagnostic, prognostic and/or predictive implications), expressed as a percentage of the total number of study participants.
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
|
Number of Participants With Adverse Events Due to Tumor Biopsies on Study
Tidsramme: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Number of participants with any adverse events possibly, probably or definitely related to tumor biopsies on study; Grading by CTCAE version 4 of adverse events.
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
|
Patient and Physician Experience
Tidsramme: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Qualitative and quantitative responses on questionnaires and personal interviews regarding patient and physician experience of this research process and their understanding of genomic analysis including perceptions of benefit versus disadvantages, impact on clinical care and decision making
|
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2011
Primær fullføring (Faktiske)
25. mars 2013
Studiet fullført (Faktiske)
21. januar 2019
Datoer for studieregistrering
Først innsendt
21. april 2011
Først innsendt som oppfylte QC-kriteriene
28. april 2011
Først lagt ut (Anslag)
2. mai 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- TGWS-001
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. .