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Comparing tumour heterogeneity in primary tumour, circulating tumour cells and metastases


- candidate number25195
- NTR NumberNTR6042
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2016
- Secondary IDsNL59037.042.16 
- Public TitleComparing tumour heterogeneity in primary tumour, circulating tumour cells and metastases
- Scientific TitleComparing tumour heterogeneity in primary tumour, circulating tumour cells and metastases
- ACRONYMCTC Autopsy study
- hypothesisNSCLC spreads using the blood. Tumour cells in the circulating system are called circulating tumour cells, and are deemed the cause of metastases, making CTCs a mayor factor in therapy efficacy and prognosis. We believe that the different compartments (original tumour, metastases and CTCs) will have differences in the genetic make up that could give insight in the metastatic process and shed light on so called 'trunc' and 'branch' mutations. To study all different compartments in detail, we will ask terminal patients to participate in a so called obduction study. After a patients death, we will obtain biopsies of the metastases and the primary tumour. When this is done the patients body will be returned to the family for burial.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC), Circulating tumor cells
- Inclusion criteria1. Patients with a histologically/cytologically proven pulmonary malignancy.
2. Patients have to have a non-curable disease state, without curative treatment options
3. Signed informed consent
4. Patients family has asserted their acceptance of the patients participation
5. Patients using anticoagulants such as fraxodi or acenocoumarol are allowed
- Exclusion criteria1. No growth factor medication
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate31-dec-2018
- Target number of participants30
- InterventionsTerminal patients are included after their informed consent and that of their families is received. We will withdraw some blood for analysis on CTCs. After the participants death, we will perform a warm autopsy to obtain samples from the primary tumour and its metastases. The patients body will subsequently be returned to the family for burial.
- Primary outcome- heterogeneity and mutational load measurements in all compartments. These can subsequently be compared to one another.
- Secondary outcome-
- Timepoints-
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESProf. Dr. H.J.M. Groen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.J.M. Groen
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD22-aug-2016 - 28-okt-2016


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