Clinical Trials

Inclusion Criteria:

Non-Cancer Arm Subjects

• Age 20 years or older.
• Able to provide a written informed consent.

Inclusion Criteria for Cancer Arm Subjects

• Age 20 years or older.
• Able to provide a written informed consent.
• Have either of the following:
  • Confirmed cancer diagnosis (any stage I-IV, as well as carcinoma in situ (CIS)) within 90 days prior to or up to 42 days after study blood draw, based upon assessment of a pathological specimen (including, but not limited to, biopsy from primary tumor site, lymph node or metastatic lesion, or cytology specimen, or bone marrow or blood specimen for hematological malignancies); or
  • A high suspicion for a cancer diagnosis by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw

Exclusion Criteria:

Non-Cancer Arm Subjects

• Known current or prior diagnosis of cancer except non-melanoma skin cancer.
  • 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 enroll.
• Oral or IV corticosteroid use in past 14 days prior to blood draw.
• Pregnancy (by self-reporth of pregnancy status).
• Current febrile illness.
• Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Poor health status or unfit to tolerate blood draw.

Cancer Arm Subjects

• Known prior diagnosis of cancer separate from the confirmed or suspected cancer diagnosis associated with study enrollment.
  • 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 enroll.
• 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.
• Pregnancy (by self-report of pregnancy status).
• Current febrile illness.
• Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Poor health status or unfit to tolerate blood draw.