Solid TumorsNCT01904916
CPCT-05 Biopsy Protocol Patient Selection
A study testing Histological biopsy procedure in people with Solid Tumors and Metastatic Disease, run by P.O. Witteveen at 3 sites in Netherlands.
Trial summary
Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR… 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
- 195 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jan 2014to Mar 2017
- 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
- Locally advanced (incurable) or metastatic cancer from a histological or cytological proven solid tumor
- Indication for systemic treatment with anti-cancer agents (with no treatment options with curative intent)
- Measurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria.
- Safe biopsy of a metastatic or locally advanced lesion possible
- No contraindications for lidocaine (or its derivatives) and/or midazolam and/or phentanyl
- Adequate organ function
Show all 10Show fewer
- WHO performance status 0-2
- Age > 18 yr
- Expected adequacy to follow up
- Written informed consent
Who cannot join
- If one or more of the above mentioned inclusion criteria is not met
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam
Erasmus Medical Center
Rotterdam
University Medical Center Utrecht
Utrecht, 3508 GX
About this study
Official title: Protocol to Obtain Tumor Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer to Improve Selection for Clinical Trials. (CPCT - 05 Biopsy Protocol Patient Selection)
Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting molecularly stratified patient populations for studies benefits the patient as it increases the odds of obtaining benefit from experimental treatment, especially in early clinical trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy are picked up in earlier phases. Therefore, broad screening of molecular lesions in the tumors of patients that are being considered for participation in trials is crucial. This pre-selection increases our ability to perform several trials in parallel and thus include more patients in more meaningful trials. With the still dismal prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials in selected patient populations is a key factor in improving prognosis.
The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are now able to deliver clinically meaningful turn-around-times. This development enables us to use this technology to enrich clinical trials using targeted therapies for patients with specific mutations.
We will obtain tumor biopsies of a metastatic or locally advanced lesion and a 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 and our own experience show that tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced solid tumors from patients that can potentially be included in clinical trials.
- Conditions
- Solid Tumors, Metastatic Disease
- 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 group | Role | What they receive |
|---|---|---|
| Histological biopsy procedure | Other | This is a diagnostic multicenter study combining histological biopsy of tumor material with DNA sequencing using Ion Torrent®, Next Generation Sequencing (NGS) platform. The study aims improve stratification of cancer patients by obtaining fresh tumor biopsies for next-generation sequencing for participation in clinical trials. Receives: Procedure: Histological biopsy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of screened patients allocated to trials based upon outcome of genetic screening effort.
Measured: 1 year
Secondary outcomes (3)
Number and nature of (serious) adverse events of the performed histological biopsies.
Measured: 2 days after each biopsy procedure
Number of samples stored for future related research.
Measured: 1 year
Number of samples with an adequate microRNA, (phospho)proteomic profiles and organoid cultures that allows biomarker discovery efforts. These profiles will be deposited in the CPCT database.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- P.O. Witteveen
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Erasmus Medical Center
- Responsible party
- Sponsor-investigator, P.O. Witteveen, UMC Utrecht
- Investigators
- Marlies Langenberg, MD, PhD, Principal investigator, UMC UtrechtNeeltje Steeghs, MD, PhD, Principal investigator, Antoni van Leeuwenhoek HospitalMaja J.A. de Jonge, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904916
- Sponsor's protocol ID
- NL.45677.041.13
- Status last verified
- Mar 2018
- First submitted
- 17 Jul 2013
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol to Obtain Tumor Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer to Improve Selection for Clinical Trials. (CPCT - 05 Biopsy Protocol Patient Selection)
- ClinicalTrials.gov ID
- NCT01904916
- Acronym / sponsor ID
- NL.45677.041.13
- Conditions
- Solid Tumors, Metastatic Disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 195 participants (actual)
- Lead sponsor
- P.O. WitteveenUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Erasmus Medical Center
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting molecularly stratified patient populations for studies benefits the patient as it increases the odds of obtaining benefit from experimental treatment, especially in early clinical trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy are picked up in earlier phases. Therefore, broad screening of molecular lesions in the tumors of patients that are being considered for participation in trials is crucial. This pre-selection increases our ability to perform several trials in parallel and thus include more patients in more meaningful trials. With the still dismal prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials in selected patient populations is a key factor in improving prognosis.
The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are now able to deliver clinically meaningful turn-around-times. This development enables us to use this technology to enrich clinical trials using targeted therapies for patients with specific mutations.
We will obtain tumor biopsies of a metastatic or locally advanced lesion and a 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 and our own experience show that tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced solid tumors from patients that can potentially be included in clinical trials.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histological biopsy procedure | Other | Procedure: Histological biopsy procedureThis is a diagnostic multicenter study combining histological biopsy of tumor material with DNA sequencing using Ion Torrent®, Next Generation Sequencing (NGS) platform. The study aims improve stratification of cancer patients by obtaining fresh tumor biopsies for next-generation sequencing for participation in clinical trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Locally advanced (incurable) or metastatic cancer from a histological or cytological proven solid tumor
- Indication for systemic treatment with anti-cancer agents (with no treatment options with curative intent)
- Measurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria.
- Safe biopsy of a metastatic or locally advanced lesion possible
- No contraindications for lidocaine (or its derivatives) and/or midazolam and/or phentanyl
Key exclusion criteria (1 listed)
- If one or more of the above mentioned inclusion criteria is not met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histological biopsy procedure | Procedure or surgery | Histological biopsy procedure |
Primary outcome
Percentage of screened patients allocated to trials based upon outcome of genetic screening effort.
Time frame: 1 year
3 secondary outcomes
Number and nature of (serious) adverse events of the performed histological biopsies.
Time frame: 2 days after each biopsy procedure
Number of samples stored for future related research.
Time frame: 1 year
Number of samples with an adequate microRNA, (phospho)proteomic profiles and organoid cultures that allows biomarker discovery efforts. These profiles will be deposited in the CPCT database.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
Related trials for Solid Tumors
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Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlies Langenberg, MD, PhD principal investigator
UMC Utrecht
Neeltje Steeghs, MD, PhD principal investigator
Antoni van Leeuwenhoek Hospital
Maja J.A. de Jonge, MD, PhD principal investigator
Erasmus Medical Center
3 sites in 1 country: see every site and its status.
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 P.O. Witteveen at 3 sites 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 10 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: stopped early, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early. Results are not available in the source record.
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 screened patients allocated to trials based upon outcome of genetic screening effort. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2018.