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CPCT-02 Biopsy Protocol (CPCT-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01855477
Recruitment Status : Recruiting
First Posted : May 16, 2013
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Hartwig Medical Foundation
Information provided by (Responsible Party):
Foundation CPCT

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. • Percentage of patients enrolled in clinical intervention trials based on the mutational profile of their cancer genome [ Time Frame: 3 months after baseline biopsy ]

Secondary Outcome Measures :
  1. Percentage of samples with sufficient DNA for sequencing analysis [ Time Frame: 1 year after baseline biopsy ]
  2. • Percentage of samples with an adequate mutational profile to allow enrollment in trials [ Time Frame: 1 year after baseline biopsy ]
  3. Differences in mutational profile pre, post and during treatment [ Time Frame: 1 year after last biopsy within one line of treatment ]
  4. • Number and nature of (serious) adverse events of the performed histological biopsies [ Time Frame: 14 days after each biopsy procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Selection criteria, defined as inclusion criteria, are:

  1. Patients with the following locally advanced or metastatic cancer for whom a new line of therapy is indicated below starting within 3 months after biopsy (see also table 2):

    - Metastatic Pancreas Cancer: FOLFIRINOX (Folinic acid [leucovorin] + Fluorouracil [5-FU] + Irinotecan + Oxaliplatin)

  2. Measurable metastatic or locally advanced lesion(s), according to RECIST 1.1 criteria18. Guidelines for response evaluation are given in appendix A.
  3. Metastatic or locally advanced lesion(s) of which a histological biopsy can safely be obtained.
  4. 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:

* If one or more of the above mentioned inclusion criteria is not met


Information from the National Library of Medicine

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


Contacts
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Contact: Martijn P Lolkema, MD, PhD +31 (0) 107041906 m.lolkema@erasmusmc.nl
Contact: Eleonora Louwman, Msc +31 (0) 10 7031802 e.louwman@erasmusmc.nl

Locations
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Netherlands
Foundation CPCT Recruiting
Rotterdam, Zuid-holland, Netherlands, 3015 GD
Contact: Martijn P. Lolkema, MD, PhD    +31 (0) 107041906    info@cpct.nl   
Sponsors and Collaborators
Foundation CPCT
Hartwig Medical Foundation
Investigators
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Principal Investigator: Martijn P Lolkema, MD, PhD Erasmus Medical Center
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Responsible Party: Foundation CPCT
ClinicalTrials.gov Identifier: NCT01855477    
Other Study ID Numbers: NL35781.041.11
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes