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- Klinische proef NCT01904916
CPCT-05 Biopsy Protocol Patient Selection
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Amsterdam, Nederland
- Antoni van Leeuwenhoek Ziekenhuis
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Rotterdam, Nederland
- Erasmus Medical Center
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Utrecht, Nederland, 3508 GX
- University Medical Center Utrecht
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
- WHO performance status 0-2
- Age > 18 yr
- Expected adequacy to follow up
- Written informed consent
Exclusion Criteria:
• If one or more of the above mentioned inclusion criteria is not met
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Histological biopsy procedure
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Percentage of screened patients allocated to trials based upon outcome of genetic screening effort.
Tijdsspanne: 1 year
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Number and nature of (serious) adverse events of the performed histological biopsies.
Tijdsspanne: 2 days after each biopsy procedure
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2 days after each biopsy procedure
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Number of samples stored for future related research.
Tijdsspanne: 1 year
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1 year
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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.
Tijdsspanne: 1 year
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1 year
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Marlies Langenberg, MD, PhD, UMC Utrecht
- Hoofdonderzoeker: Neeltje Steeghs, MD, PhD, Antoni van Leeuwenhoek Hospital
- Hoofdonderzoeker: Maja J.A. de Jonge, MD, PhD, Erasmus Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NL.45677.041.13
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Klinische onderzoeken op Histologische biopsieprocedure
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Weill Medical College of Cornell UniversityBeëindigd
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Cliniques universitaires Saint-Luc- Université...Université de LiègeWervingTaaislijmziekte | BiomarkersBelgië
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Owlstone LtdCambridge University Hospitals NHS Foundation TrustVoltooidCOVIDVerenigd Koninkrijk
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Owlstone LtdMaastricht University; OLVGVoltooid
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Modarres HospitalVoltooidComplicatie | Biopsie | ProstaatIran, Islamitische Republiek