Protocol to obtain tumor biopsies from patients with locally advanced (incurable) or metastatic cancer to improve selection for clinical trials.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1500

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
iii. APTT < 1.5 x ULN
iv. On the day of biopsy in patients using coumarines: PT-INR < 1.5
e. Biopsies should be performed at least four weeks after last bevacizumab administration (only in patients previously treated with bevacizumab).
3. Patients not known with contraindications for lidocaine (or its derivatives) or (in case of endoscopic guided biopsy procedure) midazolam and phentanyl.
4. Patients with adequate organ function as measured by:
a. Adequate liver function (only in case of planned liver biopsy):
i. Total bilirubin < 1.5 x ULN (except in case of documented Gilbert*s disease)
b. Adequate renal function (only in case of planned kidney biopsy):
i. Creatinine < 1.5 x ULN or
ii. Creatinine clearance (calculated by Cockroft) > 60 mL/min
5. WHO performance status 0-2
6. Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.

Exclusion Criteria

defined as positive selection criteria

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Percentage of screened patients with actionable genetic aberrations, defined<br /><br>as genetic aberrations known to be activating in oncogenes and inactivating in<br /><br>tumor suppressor genes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Number and nature of (serious) adverse events of the performed histological<br /><br>biopsies.<br /><br>* Number of samples stored for future related research.<br /><br>* Number of samples with an adequate microRNA, (phospo)proteomic profiles and<br /><br>organoid cultures that allows biomarker discovery efforts. These profiles will<br /><br>be deposited in the CPCT database.<br /><br>* Number of samples at progression after initial response to targeted<br /><br>treatment.</p><br>