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ACGT Newsletter

View Summer 2010 Issue

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Lastest Clinical Trial Results

ACGT aims to support clinicians and researchers as they follow scientific developments and migrate from Clinical Trials to Clinico-Genomic Trials.

The difference between the two is that in the clinico-genomic trials results from molecular  genetic research are linked to clinical and treatment data of an individual  patient offering new insights in a disease. This type of clinical trial leads to more personalized treatment capabilities by identifying more and better individual risk factors that can be applied in the future.


The table below summarizes the basic data of the breast cancer TOP trial:

Name: TOP Trial

  • EudraCT
  • Type of trial: prospective, multicentre
  • Sponsor: investigator initiated trial
  • PI: Drs M. Piccart, V. D'Hondt and C. Sotiriou
  • Start date: 16th January 2003
  • End date: 31st December 2009
  • Inclusion criteria: Early breast cancer patients, or breast cancer patients with locally advanced or inflammatory breast cancer, up to 70 years of age with a estrogen receptor-negative tumour of at least 2 cm at the ultrasound examination.
  • Exclusion criteria: metastatic breast cancer or concomitant contralateral invasive breast cancer concurrent treatment with any other anti-cancer therapy or previous treatment with anthracyclines for breast cancer.
  • No. of patients to be enrolled: appr. 400
  • Actual No. of patients: 130
  • Contact: christine.desmedt(at)bordet.be
  • Questions that are asked by the CT: are 1/topoisomerase II alpha gene amplification or protein expression, 2/ p53 gene status; 3/ gene expression profiles; 4/ proteomic profiles; 5/ predisposal genes status linked with response to anthracyclines?

 

The table below summarizes the basic data of the nephroblastoma SIOP 2001/GPOH trial:

Name: SIOP 2001/GPOH

  • EudraCT: 2007-004591-39
  • Type of trial: prospective, muliticentre, randomized
  • Sponsor: investigator initiated trial
  • PI: Prof. Dr Norbert Graf
  • Start date: 1st January 2003
  • End date: 31st December 2009
  • Inclusion criteria: patients up to 18 years of age with a kidney tumour. Adults with a nephroblastoma
  • Exclusion criteria: relapse of a nephroblastoma other treatment given before registration treatment not possible to apply.
  • No. of patients to be enrolled: 700
  • Actual No. of patients
  • Contact: graf(at)uks.eu
  • Questions that are asked by the:
    1.is doxorubicin needed in localized nephroblastoma (intermediate risk and stage II or III) 
  • 2.Do patients with nephroblastoma show a humoral antibody response against nephroblastoma specific antigens in serum and can these antibodies used for a better stratification of treatment.
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