Exploring Predictive and Prognostic Biomarkers in People with Cancer.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12623000853640

Enrollment

Registered

2023-08-08

Start date

2023-12-13

Completion date

2028-12-12

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to identify biological markers in tumour and blood samples which may predict clinical outcomes and responses to treatment for people with a variety of cancer types, including but not limited to melanoma, lung cancer, breast cancer, colorectal cancer and genitourinary cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a solid organ cancer, including but not limited to melanoma, lung cancer, breast cancer, colorectal/bowel cancer, cervical cancer, ovarian cancer, or liver cancer. Study details All participants who choose to enrol in this study will be asked to consent to having their health information (collected as part of their diagnosis and treatment) accessed by the research team. Participants who have already had tumour samples taken will be asked to consent to having some of these samples used for additional testing to determine if their tissue expresses any cancer-related genes or other biological markers. They will also be asked to provide blood samples prior to starting their cancer treatment, and again at 1 month, 3 months, 6 months, and 12 months after starting their cancer treatment. Participants may also choose to continue to provide additional blood samples every 3 months for another 3 years after starting their cancer treatment, if they wish. All samples collected for this study will undergo a range of different assessments to identify any cancer-related genes or other biological markers. Tumour and blood samples will be collected from participants as part of their routine treatment and follow-up. This means no additional blood tests or biopsy procedures will be required for this research project. It is hoped this research will identify new biological markers that can be used to determine how cancer patients may respond to different treatments, or their risk of cancer relapse post-treatment.

Interventions

Patients enrolled in this study will undergo the collection of clinical data, archival and/or excess fresh tumour specimens, and blood samples. Excess fresh tissue is residual tissue that is collected as part of a routine, standard of care biopsy. There will be no additional biopsies that are for research purposes only. Clinical data, including patient demographics, will be collected from the medical records. Patients that consent to blood collection will undergo blood sampling throughout their systemic therapy. This study will collect an additional 10-20mls at the same time when standard of care bloods are collected at baseline (before starting systemic therapy), 1 month, 3 months, 6 months, and 12 months later. Patients may also consent to additional blood collections at an interval of every 3 months, for a maximum of a 3-year follow-up period, after the initial 12-month study period. It is anticipated that an additional 5 minutes will be required to complete this study sampling for each timepoint. This is in addition to the participants' scheduled appointment time. All tumour specimens collected as part of this study will be stored on site at designated laboratories, with blood products stored frozen in a -70C designated laboratories. Once a sufficient cohort has been enrolled, selected molecular analyses will be conducted on each specimen, thus, allowing for batching of specimens. All analyses are exploratory.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Monash Health patients will be included in this study if they meet all of the following inclusion criteria: 1. Aged 18 years or older 2. Histological or cytological diagnosis of solid organ cancer 3. Able to be accessible for follow-up and data collection 4. Able to provide written, voluntary and informed consent 5. Able to undergo core needle biopsy of metastases (patients must have a lesion which is deemed medically safe to biopsy as part of routine standard of care) 6. Able to undergo collection of blood specimens during treatment.

Exclusion criteria

Monash Health patients will be excluded from this study if they meet any of the following exclusion criteria: 1. Unable to be accessible for follow-up and data collection 2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.

Outcome results