This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
PRIMARY OBJECTIVE: I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection. SECONDARY OBJECTIVES: I. Evaluate test performance at the time of initial cancer diagnosis by tumor type. II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage. OUTLINE: Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration. After completion of study, participants are followed up at 1 year.
Study Type
OBSERVATIONAL
Enrollment
2,000
Complete questionnaire
Undergo collection of tissue and blood samples
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
RECRUITINGAnchorage Radiation Therapy Center
Anchorage, Alaska, United States
SUSPENDEDAlaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
RECRUITINGAlaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Provision of blinded reference set of cancer versus non-cancer blood samples
Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.
Time frame: Up to 1 year
Test performance at the time of initial cancer diagnosis by tumor type
Diagnostic ability is assessed within each cancer type and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.
Time frame: Up to 1 year
Test performance at the time of initial cancer diagnosis by clinical stage
Diagnostic ability is assessed within each cancer stage and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.
Time frame: Up to 1 year
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Alaska Women's Cancer Care
Anchorage, Alaska, United States
RECRUITINGAnchorage Oncology Centre
Anchorage, Alaska, United States
SUSPENDEDKatmai Oncology Group
Anchorage, Alaska, United States
RECRUITINGProvidence Alaska Medical Center
Anchorage, Alaska, United States
RECRUITINGFairbanks Memorial Hospital
Fairbanks, Alaska, United States
RECRUITINGKingman Regional Medical Center
Kingman, Arizona, United States
RECRUITING...and 730 more locations