Overview

This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 clinical network sites and locations in the United States. The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection.

Eligibility

Inclusion Criteria:

• Inclusion Criteria - Both arms

Subjects must meet the following criteria in order to be included in the research study:

• Written or electronic informed consent
• Subject is 20 - 79 years of age at the time of signature of the informed consent form (ICF)
• Male or female subjects

        Inclusion Criteria Arm 1 - Cancer Subjects Arm 1 subjects enrolled in the study must meet
        the following inclusion criteria.
          -  A confirmed diagnosis or high suspicion of cancer (stage I to IV solid cancer or
             hematologic cancer) by imaging within 180 days prior to enrollment; not to include
             myelodysplastic and myeloproliferative syndromes
          -  Subject's cancer diagnosis is based upon assessment of a pathological specimen or high
             suspicion of cancer by imaging
          -  Subject's cancer is treatment-naïve
        Inclusion Criteria Arm 2 - Non-Cancer Subjects (All Cohorts)
        Arm 2 subjects enrolled in the study must meet the following inclusion criteria:
          -  Subject's health permits participation and the subject is not suspected of having
             cancer based on provider assessment.
          -  The subject was not diagnosed with cancer or received cancer treatment within the last
             5 years (persons with completely resected ductal carcinoma in-situ or non-melanoma
             skin cancer are permitted).
        Part 1B Only :
        - Subject has no known current cancer and has 1 of the follow conditions:
        o An Advanced Adenoma (AA) of the gastrointestinal tract as defined as an adenoma that is
        ≤10mm in size Subjects with any one of the criteria would be eligible High grade displasia
        or ≥10 adenoma: any size Tubulovillous adenoma, any size Tubular adenoma ≥10mm Traditional
        serrated adenoma ≥10mm
        Exclusion Criteria:
        Subject self-reporting OR available medical records at the time of screening are acceptable
        for assessment of all exclusion criteria.
        Exclusion Criteria - Both arms
        Subjects who meet any of the following criteria will be excluded from study entry:
          -  Subject is suffering from any febrile illness defined as a temperature >101.5°F within
             the last 48 hrs.
          -  Subject is pregnant (by self-report of pregnancy status).
        Exclusion Criteria Arm 1 - Cancer Subjects
        Subjects who meet any of the following criteria will be excluded from study entry:
          -  Subject with a prior history of cancer within 5 years will not be allowed to
             participate in the study
          -  More than 1 active cancer diagnosis (ie. a subject presenting with recurrent breast
             cancer and newly diagnosed lung cancer would be excluded; subject with prior (>5 years
             ago) treated breast cancer without recurrence and presenting with newly diagnosed lung
             cancer would be eligible).
          -  Subject is currently receiving, or has in the past received, any of the following
             definitive therapies to treat their current cancer:
               -  Surgical treatment, surgical removal, or surgical management of the cancer beyond
                  that required to establish the cancer diagnosis. Surgical or biopsy procedures
                  that remove more tissue than required to establish the cancer diagnosis, or that
                  were performed to manage symptoms or initiate cancer treatment prior to blood
                  sample collection will be considered 'definitive' and are not permissible
                  regardless of the residual tumor mass remaining in the subject.
               -  Chemotherapy (local, regional, or systemic) including chemoembolization targeted
                  therapy;
               -  Immunotherapy including cancer vaccines;
               -  Hormone therapy; or
               -  Radiation therapy (a single dose of palliative radiation prior to study start is
                  allowed).
          -  The subject is a recipient of an organ transplant or prior non-autologous (allogeneic)
             bone marrow or stem cell transplant.
          -  Subject who has undergone a bowel preparation for a gastrointestinal malignancy within
             3 days of an anticipated blood draw.
        Exclusion Criteria Arm 2 - Non-cancer Subjects
        Subjects who meet any of the following criteria will be excluded from study entry:
        - The subject is the recipient of an organ transplant or prior non-autologous (allogeneic)
        bone marrow or stem cell transplant.