Development of a platform for next-generation DNA sequencing based personalized treatment for cancer patients: Protocol to obtain biopsies from patients with locally advanced or metastatic cancer.

Completed

Conditions: 10027476
Locally advanced or metastatic solid tumors

Registration Number: NL-OMON53030

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 7500

Inclusion Criteria

* Patient with the following locally advanced or metastatic cancer for whom a
new line of therapy is indicated starting within 3 months after biopsy:
- Metastatic Pancreas Cancer: FOLFIRINOX (Folinic acid [leucovorin] +
Fluorouracil [5-FU] + Irinotecan + Oxaliplatin)
- Metastatic Bladder Cancer (including Renal Cell Cancer and all types of
Urothelial Cell Cancer): Pembrolizumab
* Measurable metastatic or locally advanced lesion(s), according to RECIST 1.1
criteria.. Guidelines for response evaluation are given in appendix A.
* Metastatic or locally advanced lesion(s) of which a histological biopsy can
safely be obtained.
* Patients age > 18 years, willing and able to comply with the protocol as
judged by the investigator with a signed informed consent.

Patients must meet selection criteria 3 not only prior to baseline biopsy, but
also prior to the (optional and if applicable, see CPCT-02 Study manual)
post-treatment biopsies.

Exclusion Criteria

No locally advanced or metastatic cancer.
Age below 18 years

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients enrolled in clinical intervention trials based on the<br /><br>mutational profile of their cancer genome </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Percentage of samples with sufficient DNA for sequencing analysis<br /><br>- Percentage of samples with an adequate mutational profile to allow enrollment<br /><br>in trials<br /><br>- Database of all (anonymized) data obtained using this protocol<br /><br>- Differences in mutational profile pre, post and during treatment<br /><br>- Number and nature of all (serious) adverse events of the performed<br /><br>histological biopsies<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 filled in questionnaires, sufficient for performing e.g. health<br /><br>economic analysis or PROM research.</p><br>