Bladder cancer, breast cancer, colorectal cancer, lung cancer, melanoma cancer, oesophageal cancer, ovarian cancer, pancreatic cancer, prostate cancer and renal cancer Cancer
Conditions
Interventions
This is a prospective, observational, case-control study for the collection of blood for the training and evaluation of the EnlightenTM Multi-Cancer Early Detection test. The test is comprised of two
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Able to provide a written informed consent 3. Willing to provide 4 mL blood sample at the time of enrolment
Exclusion criteria
Exclusion criteria: All Participants: 1. Pregnancy (by self-report of pregnancy status), or pregnancy within the last 12 months 2. Current febrile illness 3. Infection requiring hospitalisation within 30 days prior to blood draw 4. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw. 5. Undergone a surgical procedure (including diagnostic biopsy) within 30 days prior to blood draw 6. Undergone a blood transfusion within 30 days prior to blood draw 7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant 8. Poor health status or unfit to tolerate blood draw Confirmed Cancer Cohort: 9. Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of the cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy 10. Known prior diagnosis of cancer, per guidance in protocol, separate from the confirmed or suspected cancer diagnosis associated with study enrolment. Exception: subjects with history of non-melanoma skin cancer (e.g., BCC or SCC) that has been effectively and exclusively managed by local or focal therapies such as surgical resection, radiation therapy, cryotherapy or topical therapy, are eligible to enrol. 11. Cancer recurrence 12. Synchronous malignancies Symptomatic and Asymptomatic Cancer-Free Cohort: 13. Known current or prior diagnosis of cancer, per guidance in protocol. Exception: subjects with history of non-melanoma skin cancer (e.g., BCC or SCC) that has been effectively and exclusively managed by local or focal therapies such as surgical resection, radiation therapy, cryotherapy or topical therapy, are eligible to enrol. 14. Oral or IV corticosteroid use in past 14 days prior to blood draw
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer status (presence versus absence of cancer) measured by a cancer diagnosis being present in routine NHS diagnostic records by the end of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tissue of Origin (1 of 10 solid tumour cancers) measured using the stated Tissue of Origin for the first cancer diagnosis present in routine NHS diagnostic records by the end of follow-up. 2. Cancer stage (stage I/II/III/IV) measured using the stated cancer stage for the first cancer diagnosis present in routine NHS diagnostic records by the end of follow-up. | — |
Countries
England, United Kingdom
Contacts
Public ContactHannah Warming
Outcome results
None listed