Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid Tumor Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample Collection for Genome-Wide Sequencing | Other | Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients from the Princess Margaret Hospital or other Ontario Institution
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lillian Siu, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of the 56 participants approached, 50 agreed and consented to the study, and 49 had successful biopsies.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | calendar days | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 2 Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 1 Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet E. Dancey | Ontario Institute for Cancer Research | 1-613-533-6430 | janet.dancey@oicr.on.ca |
Not provided
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Archival tumor tissue, fresh tumor biopsy, blood sample, pleural effusion (if available)or ascites (if available)
| 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. | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
| 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 | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Time Since Metastatic Diagnosis (Months) | Median | Full Range | months |
|
| Number of Prior Treatment Regimens | Median | Full Range | prior treatment regimens |
|
| Primary Tumour Type | Count of Participants | Participants |
|
| Participants |
|
|
| 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. | Posted | Count of Participants | Participants | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
|
|
|
| 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 | Data were not collected. | Posted | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. |
|
|
| 2 |
| 49 |
| 6 |
| 49 |
| Grade 3 Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Grade 1 Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Grade 2 Wound Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided