Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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. Patients with a cancer diagnosis may undergo collection of tissue samples at registration. After completion of study, participants are followed up at 1 year.

Intervention public domain (ClinicalTrials.gov)

Other: Questionnaire Administration. Complete questionnaire

Intervention public domain (ClinicalTrials.gov)

Procedure: Biospecimen Collection. Undergo collection of tissue and blood samples

Arm public domain (ClinicalTrials.gov)

Screening (questionnaire, biospecimen collection) (): 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.

Primary outcome public domain (ClinicalTrials.gov)

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.

Secondary outcome public domain (ClinicalTrials.gov)

Test performance at the time of initial cancer diagnosis by tumor type. Time frame: Up to 1 year.

Secondary outcome public domain (ClinicalTrials.gov)

Test performance at the time of initial cancer diagnosis by clinical stage. Time frame: Up to 1 year.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * Participants with a cancer diagnosis: Documentation of disease: * Histologic documentation: Histologically confirmed diagnosis of invasive cancer * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma \*\* For leukemia: Type (chronic lymphocytic leukemia \[CLL\], chronic myeloid leukemia \[CML\], acute lymphoblastic lymphoma \[ALL\], acute myeloid leukemia \[AML\]) * For lymphoma (any type): Stage I-IV based on Ann Arbor staging * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS) * One of the following tumor types (synchronous cancers are not allowed and all neuroendocrine tumors are excluded): * Colorectal * Bladder * Head and neck * Hepatobiliary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Lung * Lymphoma * Leukemia * Ovary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Pancreas \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Multiple myeloma * Gastric, esophageal or gastroesophageal * Breast * Thyroid * Kidney \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Endometrium \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Prostate * Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention (including surgical excision) * Participants with a cancer diagnosis: Age \>= 40 and =\< 75 * Participants with a cancer diagnosis: No known current pregnancy by self-report * Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy other than the current cancer diagnosis. Non-melanoma skin cancers (such as basal or squamous cell) are …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 2900 participants (estimated).