None listed
Conditions
Brief summary
The primary purpose of the NOMINATOR research study is to determine if new techniques for gene sequencing can be used in the treatment of rare cancers. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with a rare cancer which has few standard treatment options and is associated with poor outcome. Study details: All participants enrolled in this trial will provide samples of blood and tumour tissue either via retrieval of stored tumour sample from another lab/biobank if this is available or by undergoing a biopsy procedure to obtain fresh samples of tumour. These samples will be used for the gene sequencing test. We will also collect health information from the participant (either via direct questioning by their doctor or from their medical records), in order to help researchers interpret the genomic sequencing results which are obtained from testing. A panel of cancer experts will review the genomic sequencing results and provide advice about treatments that could potentially be more effective as a result of those findings. The patient will then have the option to receive the results of this testing (this is optional), and their doctor may be able to use these tests results to better determine an effective treatment and management plan for their disease. It is hoped that understanding a cancer’s genomic profile may help doctors to select appropriate treatment options, according to the particular genomic profile of that person’s cancer. This trial will provide information on whether this is feasible in practice.
Interventions
Eligible participants will consent to the collection of tumour tissue and up to three blood samples. If clinically indicated, a tumour biopsy will be performed for some participants, or an archival sample of the tumour will be retrieved for a gene sequencing test. The study will use gene sequencing to identify genetic mutations present in a person’s cancer cells (a cancer genomic profile). Following analysis of the samples, each case will be discussed in a Molecular Tumour Board with the involve
Eligible participants will consent to the collection of tumour tissue and up to three blood samples. If clinically indicated, a tumour biopsy will be performed for some participants, or an archival sample of the tumour will be retrieved for a gene sequencing test. The study will use gene sequencing to identify genetic mutations present in a person’s cancer cells (a cancer genomic profile). Following analysis of the samples, each case will be discussed in a Molecular Tumour Board with the involvement of a range of relevant experts, including scientists, bioinformaticians, specialists in genetics and oncologists. The Molecular Tumour Board will comment on validated or promising treatments as a result of the genomic analysis - these will not be limited to locally available or PBS funded medications. Recommendations are non-prescriptive and the patient’s treating oncologist will decide on treatment options. Results of the gene sequencing test will be sent to the participant’s treating oncologist. Participants may elect to receive the results of the gene sequencing test from their treating oncologist, or to attend a visit at the hospital. After the results have been discussed, participants will be asked to fill out questionnaires that will ask about participation in the study, and whether or not they feel that the gene sequencing test has been helpful in terms of choosing future treatment options. Participants will be asked to: *attend a screening visit to have some tests done to assess whether or not the NOMINATOR study is suitable for them; *attend one or more hospital visits to collect blood and tumour samples and complete a baseline questionnaire; *attend an optional hospital visit to receive the results of the gene sequencing test and to complete a questionnaire; *attend up to two more visits to the hospital for blood tests which will be used to track circulating tumour DNA which may help identify response to treatment (this analysis is exploratory). *complete questionnaires at 6, 12 and at 24 months (participants may complete questionnaires during hospital visits or by mail).
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged over 18 years, with signed informed consent and ability to comply with protocol requirements * Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patients with a life expectance of >12 weeks * Access to tumour tissue is available from core biopsy or surgical resection from a disease site * Histologically confirmed rare histopathology diagnosis according to the RARECARE group definition * Malignancy where little evidence-based care or standard of care therapies exist * Tumour type associated with a poor outcome
Exclusion criteria
* Patients who are unable, or unwilling to consent to the study. * Patients who have a concurrent active malignancy other than adequately treated non-melanomatous skin cancer, early prostatic adenocarcinoma treated with curative intent or non-invasive carcinoma / in-situ neoplasm of the cervix or breast. Patients with a previous history of malignancy will be eligible provided they have been disease-free for >5 years.
Outcome results
None listed