NL-OMON40487
Completed
Not Applicable
Protocol to obtain tumor biopsies from patients with locally advanced (incurable) or metastatic cancer to improve selection for clinical trials. - CPCT-05 biopsy protocol patient selection
niversitair Medisch Centrum Utrecht0 sites1,500 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- metastatic cancer
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 1500
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with cancer who are eligible to enter into a trial with systemic anti\-cancer therapy. A CPCT\-05 biopsy may be combined with a diagnostic biopsy at all instances, if deemed appropriate for selection for study participation.Exempt from biopsy: glioblastoma patients who have undergone surgery with adequate histological material available for identification of tumor specific mutations.
- •2\. Histologic biopsy can safely be obtained:
- •a. Patients with safely accessible lesions according to the medical specialist performing the biopsy procedure.
- •b. Patients not known should not have with known bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
- •c. Patients must not using use any anti\-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID\*s, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted. If the medical specialist performing the biopsy of a superficial lesion agrees with performing the biopsy procedure while the patient is on anticoagulant therapy other than therapeutically dosed coumarines, LMWHs and oral Xa inhibitors, the biopsy may be performed with caution.
- •d. Adequate hematology and coagulation status as measured by
- •:i. Hb \> 6\.0 mmol/L
- •Note: Red blood cell transfusions are allowed to increase the Hb.
- •Platelet count \>100 x 109/L
- •ii. PT \< 1\.5 x ULN or PT\-INR \< 1\.5
Exclusion Criteria
- •defined as positive selection criteria
Outcomes
Primary Outcomes
Not specified
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