Development of a Platform for Next-generation DNA Sequencing Based Personalized Treatment for Cancer Patients: Protocol to Obtain Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer (CPCT - 02 Biopsy Protocol)
18 Years
N/A
Both
Solid Tumors, Metastatic Disease
Trial Information
Development of a Platform for Next-generation DNA Sequencing Based Personalized Treatment for Cancer Patients: Protocol to Obtain Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer (CPCT - 02 Biopsy Protocol)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)
Outcome Measure:
• Percentage of patients enrolled in clinical intervention trials based on the mutational profile of their cancer genome
Outcome Time Frame:
3 months after baseline biopsy
Safety Issue:
No
Principal Investigator
Martijn P. Lolkema, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UMC Utrecht
Authority:
The Netherlands: Institutional Review Board of the Universerity Medical Center Utrecht, Dutch Cancer Institute in Amsterdam and Erasmus Medical Center in Rotterdam
Study ID:
NL35781.041.11
NCT ID:
NCT01855477
Start Date:
August 2011
Completion Date:
Related Keywords:
- Solid Tumors
- Metastatic Disease
- Neoplasm Metastasis
Name | Location |
|---|
