Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01904916
Status:
TERMINATED
Last Update Posted:
2018-03-09
First Post:
2013-07-17
Brief Title:
CPCT-05 Biopsy Protocol Patient Selection
Sponsor:
PO Witteveen
Organization:
UMC Utrecht
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None