N/A
N=50
Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01345513 ↗Enrolled (actual)
50
Serious AEs
4.1%
Results posted
Mar 2020
Primary outcome: Primary: Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients — 21 calendar days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sample Collection for Genome-Wide Sequencing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients |
21 | — |
| SECONDARY Number of Participants With Actionable Genomic Results |
16 | — |
| SECONDARY Number of Participants With Adverse Events Due to Tumor Biopsies on Study |
6; 2 | — |
| SECONDARY Patient and Physician Experience |
— | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01345513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.