Solid Tumors
Conditions
Keywords
Genomic Analysis, Sequencing, Genetic, Biopsy, Solid tumors
Brief 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.
Detailed description
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.
Interventions
OTHERSample Collection for Genome-Wide Sequencing
Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Actionable Genomic Results | 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. |
| Number of Participants With Adverse Events Due to Tumor Biopsies on Study | 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. |
| Patient and Physician Experience | 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solid Tumor Cancer Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available) | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Solid Tumor Cancer | — |
|---|---|---|
| Age, Continuous | 57 years | — |
| Number of Prior Treatment Regimens | 3 prior treatment regimens | — |
| Primary Tumour Type Anal | 2 Participants | — |
| Primary Tumour Type Breast | 8 Participants | — |
| Primary Tumour Type Colorectal | 9 Participants | — |
| Primary Tumour Type Head & Neck | 2 Participants | — |
| Primary Tumour Type Mesothelioma | 2 Participants | — |
| Primary Tumour Type NSCLC | 5 Participants | — |
| Primary Tumour Type Other | 11 Participants | — |
| Primary Tumour Type Ovarian | 8 Participants | — |
| Primary Tumour Type Prostate | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
| Time Since Metastatic Diagnosis (Months) | 17.2 months | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 49 |
| serious Total, serious adverse events | 2 / 49 |
Outcome results
Primary
Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
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.
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Solid Tumor Cancer | Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients | 21 calendar days |
Secondary
Number of Participants With Actionable Genomic Results
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.
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Solid Tumor Cancer | Number of Participants With Actionable Genomic Results | 16 Participants |
Secondary
Number of Participants With Adverse Events Due to Tumor Biopsies on Study
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.
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Population: Of the 49 patients analyzed, 8 experienced adverse events related to tumour biopsies during the study. Minor events included bruising, bleeding and minor infections. Serious events included pneumothorax and cellulitis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solid Tumor Cancer | Number of Participants With Adverse Events Due to Tumor Biopsies on Study | Minor (as per CTCAE) | 6 Participants |
| Solid Tumor Cancer | Number of Participants With Adverse Events Due to Tumor Biopsies on Study | Serious (as per CTCAE) | 2 Participants |
Secondary
Patient and Physician Experience
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
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Population: Data were not collected.