Summary

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate a test 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 researcher develop test for the early detection of cancers.

Objectives

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.
III. Evaluate test performance at the time of initial cancer diagnosis by type and stage separately for white non-Hispanic subjects and for minority subjects (subjects that are not white non-Hispanic).
Iv. Determine whether test performance is different for white non-Hispanic subjects compared to minorities.

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.

Eligibility

1. 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 ** Melanoma *** 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 ** Sarcoma
2. Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention (including surgical excision)
3. Participants with a cancer diagnosis: Age >= 40 and =< 75
4. Participants with a cancer diagnosis: No known current pregnancy by self-report
5. 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 allowed
6. Participants with a cancer diagnosis: Willingness to provide blood samples for research use
7. Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL
8. Participants with a cancer diagnosis: No history of organ transplantation
9. Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
10. Participants without a cancer diagnosis and without suspicion of cancer: Age >= 40 and =< 75
11. Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report
12. Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy. Non-melanoma skin cancers (such as basal or squamous cell) are allowed
13. Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use
14. Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
15. Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation
16. Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
17. Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, hepatobiliary cancer, endometrial cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw * Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma
18. Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs
19. Participants with a high suspicion of cancer: Age >= 40 and =< 75
20. Participants with a high suspicion of cancer: No known current pregnancy by self-report
21. Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy.Non-melanoma skin cancers (such as basal or squamous cell) are allowed
22. Participants with a high suspicion of cancer: Willingness to provide blood samples for research use
23. Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
24. Participants with a high suspicion of cancer: No history or organ transplantation
25. Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages

Treatment Sites in Georgia