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.
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.
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.
