CPCT-05 Biopsy Protocol Patient Selection

NCT01904916 | Terminated DMC

• 1 other identifier: NL.45677.041.13
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 3

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Percentage of screened patients allocated to trials based upon outcome of genetic screening effort.

  1 year

Secondary Outcomes (3)

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

  2 days after each biopsy procedure

• Number of samples stored for future related research.

  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.

  1 year

Study Arms (1)

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.

Procedure: Histological biopsy procedure

Interventions

Histological biopsy procedure PROCEDURE

Histological biopsy procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• P.O. Witteveen: lead
• The Netherlands Cancer Institute: collaborator
• Erasmus Medical Center: collaborator

Study Sites (3)

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508 GX, Netherlands

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlies Langenberg, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Neeltje Steeghs, MD, PhD

  Antoni van Leeuwenhoek Hospital

  PRINCIPAL INVESTIGATOR

• Maja J.A. de Jonge, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

NL (3)