CPCT-02 Biopsy Protocol (CPCT-02)
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|ClinicalTrials.gov Identifier: NCT01855477|
Recruitment Status : Recruiting
First Posted : May 16, 2013
Last Update Posted : August 27, 2020
A major challenge for researchers in cancer care is to expedite the development of new therapeutics and the Center for Personalized Cancer Treatment (a collaboration of the Dept. of Medical Oncology from the University Medical Center Utrecht, Netherlands Cancer Center - Antoni van Leeuwenhoek hospital and the Erasmus Medical Center - Daniël den Hoed clinic) is an initiative to achieve this goal.
The current and future generation anti-cancer drugs are developed to specifically activate or deactivate deregulated gene products or signaling pathways in cancer cells. The development of such "targeted" agents is an exciting new opportunity that promises to deliver more anti-cancer efficacy and less toxicity. Although targeted therapy has been a breakthrough in medical oncology leading to the development of a portfolio of potentially successful new drugs, it has not yet delivered the much needed relief for large patient populations. We believe that the development of these agents is mainly hampered by our lack of successful patient selection.
The CPCT aims to select patients for clinical trial participation based on the results of Next Generation Sequencing (NGS) information obtained from tumor material. The advent of NGS platforms enables us to probe a significant proportion of the cancer genome and thus to develop a realistic view on the complex genetic changes in cancer cells. The CPCT aims to use NGS platforms to improve the selection of patients for targeted therapy trials.
We will obtain tumor biopsies of a (preferably) metastatic or locally advanced lesion and peripheral blood sample from all patients included in the trial; the biopsies to obtain information on the tumor related genetic mutations (mutational profile) and the blood samples to assess each patient's germline DNA background variation. As patients will be asked to undergo an invasive procedure it is important to address the potential safety issues. Review of the literature shows that in general tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced (incurable) solid tumors and we aim to use the information obtained from DNA sequencing to stratify patients for inclusion in clinical trials. The final personalized treatment decision will be made dependent on the availability of trials and the expected predictive value of the mutational profile.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Metastatic Disease||Procedure: Histological biopsy procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Histological biopsy procedure
This is a multicenter study combining histological biopsy of tumor material with DNA sequencing using Next Generation Sequencing (NGS) platform. The study aims to obtain a more accurate pre-treatment stratification of cancer patients by obtaining fresh tumor biopsies for next-generation sequencing to obtain a mutational profile.
Procedure: Histological biopsy procedure
- • Percentage of patients enrolled in clinical intervention trials based on the mutational profile of their cancer genome [ Time Frame: 3 months after baseline biopsy ]
- Percentage of samples with sufficient DNA for sequencing analysis [ Time Frame: 1 year after baseline biopsy ]
- • Percentage of samples with an adequate mutational profile to allow enrollment in trials [ Time Frame: 1 year after baseline biopsy ]
- Differences in mutational profile pre, post and during treatment [ Time Frame: 1 year after last biopsy within one line of treatment ]
- • Number and nature of (serious) adverse events of the performed histological biopsies [ Time Frame: 14 days after each biopsy procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855477
|Contact: Martijn P Lolkema, MD, PhD||+31 (0) firstname.lastname@example.org|
|Contact: Eleonora Louwman, Msc||+31 (0) 10 email@example.com|
|Rotterdam, Zuid-holland, Netherlands, 3015 GD|
|Contact: Martijn P. Lolkema, MD, PhD +31 (0) 107041906 firstname.lastname@example.org|
|Principal Investigator:||Martijn P Lolkema, MD, PhD||Erasmus Medical Center|