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.

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. - CPCT - 02 biopsy protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53030

Enrollment

7500

Registered

2011-08-01

Start date

2011-08-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic solid tumors

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: No locally advanced or metastatic cancer. Age below 18 years

Design outcomes

Primary

Measure	Time frame
Percentage of patients enrolled in clinical intervention trials based on the mutational profile of their cancer genome	—

Secondary

Measure	Time frame
Secondary endpoints: - Percentage of samples with sufficient DNA for sequencing analysis - Percentage of samples with an adequate mutational profile to allow enrollment in trials - Database of all (anonymized) data obtained using this protocol - Differences in mutational profile pre, post and during treatment - Number and nature of all (serious) adverse events of the performed histological biopsies - Number of samples with an adequate microRNA, (phospo)proteomic profiles and organoid cultures that allows biomarker discovery efforts. These profiles will be deposited in the CPCT database. - Number of filled in questionnaires, sufficient for performing e.g. health economic analysis or PROM research.	—

Measure

Time frame

Secondary endpoints: - Percentage of samples with sufficient DNA for sequencing analysis - Percentage of samples with an adequate mutational profile to allow enrollment in trials - Database of all (anonymized) data obtained using this protocol - Differences in mutational profile pre, post and during treatment - Number and nature of all (serious) adverse events of the performed histological biopsies - Number of samples with an adequate microRNA, (phospo)proteomic profiles and organoid cultures that allows biomarker discovery efforts. These profiles will be deposited in the CPCT database. - Number of filled in questionnaires, sufficient for performing e.g. health economic analysis or PROM research.

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Countries

Netherlands

Outcome results