Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-01-01
2023-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Tumor tissue and blood sample collection
Fresh tumor tissue biopsy
A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
Blood draw
Blood will be taken by a needle from a vein.
Archival tumor tissue collection
A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
Interventions
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Fresh tumor tissue biopsy
A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
Blood draw
Blood will be taken by a needle from a vein.
Archival tumor tissue collection
A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
Eligibility Criteria
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Inclusion Criteria
* Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
* Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
* Patients must be fit enough to safely undergo a tumor biopsy as judged by the investigator.
* Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
* Life expectancy of greater than 90 days, as judged by the investigator.
* Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
* Patients must undergo systemic treatment with gemcitabine or 5-FU based regimens as first line standard systemic palliative treatment with or without other investigational agents within a clinical trial.
* Ability to understand and willing to sign a written informed consent document.
Exclusion Criteria
* Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
* Patients who are currently on anti-cancer treatment including chemotherapy.
* Patients with known brain metastases are excluded from participation in this clinical study.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Jennifer J Knox, M.D.
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Other Identifiers
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COMPASS-B
Identifier Type: -
Identifier Source: org_study_id
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