This is an observational and sample collection study involving patients (alive or deceased) from several clinical trials who had received the investigational drug, olaparib in other research studies. There is no intervention given for this study. This research is being done to understand of the mechanisms involved in patients whose cancer responds well and whose cancer does not respond well to investigational drug, olaparib, to help better understand how olaparib works and to better identify patients who may benefit from this therapy.
This is study will compare biomarker research with response in patients who have received olaparib. Patients who have had a durable response to olaparib for at least 2 years will be approached for the study. Patients who agree to this study will then have their medical history collected and will be asked to complete a questionnaire. Archival tumor tissue will also be collected for biomarker research. A waiver of consent is requested to access the medical records and archival tumor tissue of patients who are deceased. If participants are still taking olaparib, they will be asked to provide blood samples for pharmacokinetics and circulating tumor DNA, and the results of CT scans taken as part of their standard of care or as a part of another research study. If participants' disease worsens while still on olaparib, they will then be asked to provide a blood sample for pharmacogenomics and BRCA testing (if not known). An optional tumor biopsy will also be requested. Participants will continue to be followed by telephone for survival and any new treatments they are receiving.
Study Type
OBSERVATIONAL
Enrollment
118
South Eastern Sydney Local Health District
Randwick, New South Wales, Australia
British Columbia Cancer Centre
Vancouver, British Columbia, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Institute of European Oncology
Milan, Italy
Vall d'Hebron
Barcelona, Spain
The Royal Marsden
Sutton, England, United Kingdom
Edinburgh Cancer Research Centre
Edinburgh, Scotland, United Kingdom
The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
Time frame: 4 years
The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.
Time frame: 4 years
The number and types of mutated genes.
Time frame: 4 years
The number of patients with antibodies to the study drug
Time frame: 4 years
Evaluate the levels of PI3K/Akt pathway expression per patient
Time frame: 4 years
HRR deficiency profile
Time frame: 4 years
Level of poly (ADP-ribose) (PAR) expression
Time frame: 4 years
Signature of PARP response compared with signature of platinum sensitivity
Time frame: 4 years
Signature of PARP response and PARP resistance on different tumour sites
Time frame: 4 years
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