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Solid TumorsCPCT-02NCT01855477

CPCT-02 Biopsy Protocol

A study testing Histological biopsy procedure in people with Solid Tumors and Metastatic Disease, run by Foundation CPCT at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Metastatic Disease
What is being tested?
Histological biopsy procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,927 participants
Where
1 siteNetherlands
Study dates
17 Aug 2011to 18 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Foundation CPCT, Radboud UMC

    Nijmegen, South Holland, 6500 HB

Other trials in Netherlands

About this study

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)

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.

Read more

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.

Being tested
Histological biopsy procedure
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Histological biopsy procedureProcedure or surgery

Study groups in NCT01855477
Study groupRoleWhat they receive
Histological biopsy procedureOtherThis 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.
Receives: Procedure: Histological biopsy procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • Percentage of patients enrolled in clinical intervention trials based on the mutational profile of their cancer genome

    Measured: 3 months after baseline biopsy

Secondary outcomes (4)

  1. Percentage of samples with sufficient DNA for sequencing analysis

    Measured: 1 year after baseline biopsy

  2. • Percentage of samples with an adequate mutational profile to allow enrollment in trials

    Measured: 1 year after baseline biopsy

  3. Differences in mutational profile pre, post and during treatment

    Measured: 1 year after last biopsy within one line of treatment

  4. • Number and nature of (serious) adverse events of the performed histological biopsies

    Measured: 14 days after each biopsy procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2013 (estimated)
  2. Study start17 Aug 2011
  3. Primary completion1 Jul 2023
  4. Study completion18 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6,927 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855477
Sponsor's protocol ID
NL35781.041.11
Acronym
CPCT-02
Status last verified
Jul 2024
First submitted
13 May 2013
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Vis DJ, Palit SAL, Corradi M, Cuppen E, Mehra N, Lolkema MP, Wessels LFA, van der Heijden MS, Zwart W, Bergman AM. Whole genome sequencing of 378 prostate cancer metastases reveals tissue selectivity for mismatch deficiency with potential therapeutic implications. Genome Med. 2025 Mar 20;17(1):24. doi: 10.1186/s13073-025-01445-5.

    PubMed 40114169

  • van de Haar J, Mankor JM, Hummelink K, Monkhorst K, Smit EF, Wessels LFA, Cuppen E, Aerts JGJV, Voest EE. Combining Genomic Biomarkers to Guide Immunotherapy in Non-Small Cell Lung Cancer. Clin Cancer Res. 2024 Apr 1;30(7):1307-1318. doi: 10.1158/1078-0432.CCR-23-4027.

    PubMed 38300729

  • Verschoor N, Smid M, Jager A, Sleijfer S, Wilting SM, Martens JWM. Integrative whole-genome and transcriptome analysis of HER2-amplified metastatic breast cancer. Breast Cancer Res. 2023 Nov 15;25(1):145. doi: 10.1186/s13058-023-01743-z.

    PubMed 37968696

  • de Joode K, van de Geer WS, van Leenders GJLH, Hamberg P, Westgeest HM, Beeker A, Oosting SF, van Rooijen JM, Beerepoot LV, Labots M, Mathijssen RHJ, Lolkema MP, Cuppen E, Sleijfer S, van de Werken HJG, van der Veldt AAM. The genomic and transcriptomic landscape of advanced renal cell cancer for individualized treatment strategies. Sci Rep. 2023 Jul 3;13(1):10720. doi: 10.1038/s41598-023-37764-z.

    PubMed 37400554

  • Nakauma-Gonzalez JA, Rijnders M, van Riet J, van der Heijden MS, Voortman J, Cuppen E, Mehra N, van Wilpe S, Oosting SF, Rijstenberg LL, Westgeest HM, Zwarthoff EC, de Wit R, van der Veldt AAM, van de Werken HJG, Lolkema MPJ, Boormans JL. Comprehensive Molecular Characterization Reveals Genomic and Transcriptomic Subtypes of Metastatic Urothelial Carcinoma. Eur Urol. 2022 Apr;81(4):331-336. doi: 10.1016/j.eururo.2022.01.026. Epub 2022 Jan 25.

    PubMed 35086719

  • Roepman P, de Bruijn E, van Lieshout S, Schoenmaker L, Boelens MC, Dubbink HJ, Geurts-Giele WRR, Groenendijk FH, Huibers MMH, Kranendonk MEG, Roemer MGM, Samsom KG, Steehouwer M, de Leng WWJ, Hoischen A, Ylstra B, Monkhorst K, van der Hoeven JJM, Cuppen E. Clinical Validation of Whole Genome Sequencing for Cancer Diagnostics. J Mol Diagn. 2021 Jul;23(7):816-833. doi: 10.1016/j.jmoldx.2021.04.011. Epub 2021 May 6.

    PubMed 33964451

  • Mendelaar PAJ, Smid M, van Riet J, Angus L, Labots M, Steeghs N, Hendriks MP, Cirkel GA, van Rooijen JM, Ten Tije AJ, Lolkema MP, Cuppen E, Sleijfer S, Martens JWM, Wilting SM. Whole genome sequencing of metastatic colorectal cancer reveals prior treatment effects and specific metastasis features. Nat Commun. 2021 Jan 25;12(1):574. doi: 10.1038/s41467-020-20887-6.

    PubMed 33495476

Questions about this trial

What is this clinical trial studying?

A study testing Histological biopsy procedure in people with Solid Tumors and Metastatic Disease, run by Foundation CPCT at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• Percentage of patients enrolled in clinical intervention trials based on the mutational profile of their cancer genome (time frame: 3 months after baseline biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01855477, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.

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